GMP, cGMP, QSR and FDA Resource Library
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Articles by David Markovitz
Personal Productivity
FDA Resources
Timely Resource Articles
cGMP for Dietary Supplements
cGMP for PET Drugs
INDs - CGMPsDuring Phase I Clinical Trials
Medical Gases
Medical Devices
Breaking News
Congratulations to one of our clients - VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center - for receiving the 2009 Malcolm Baldrige National Quality Award. We are privileged to share in your success!
The Malcolm Baldrige National Quality Award is the most prestigious Quality Award in the USA. Read a Press Release with details of their accomplishment. VA Cooperative Studies Program Clinical Research
Articles authored by David Markovitz
NEW!
Using Stories, Anecdotes, and Metaphors to Makes Your GMP Training Come Alive This article describes techniques for making your training become memorable experiences
NEW!
Creating a Culture of Quality and GMP Compliance - This article describes characteristics of companies where Quality and GMP Compliance have become a Lifestyle
NEW!
GMP Training in a Down Economy: Why It's More Critical Now Than Ever - This article will help you make the case for NOT cutting back on training in tough financial times
NEW!
GMP Training: Keep it Fresh by Making it Real - This article contains tips on keeping your GMP fresh
NEW!
GMP and Safety: Employee Safety and Customer Safety - This article discusses how to integate GMP training into your safety training sessions
Practical Preparation for Effective GMP Training Six Steps to Success! - First published in the Journal of GXP Compliance, this article is the first of three parts aimed at developing an effective GMP training process.
Conducting Effective GMP Training: Do’s and Don’ts for Success! - First published in the Journal of GXP Compliance, this is the second of three parts.
Effective Follow-up Strategies to GMP Training - First published in the Journal of GXP Compliance, this is the final of three parts.
A Risk-based Approach to GXP Training: One Size Does Not Fit All - First published in the Journal of GXP Compliance, this article explores developing an effective GMP training process in sync with FDA's new risk-based approach.
A System of Leadership for the 21st Century Lessons from Theodore Roosevelt - An unique perspective building on David's innovative approach of bringing Teddy Roosevelt Back to Life.
Problem Solving is Not Good Enough! Problem Prevention is the Key to Success - Effective use of After Action Reviews.
Personal Productivity
100 Ways to Kill a Concept: Why Most Ideas Get Shot Down - This short e-book will help you become better at "selling" your ideas and creating a culture of innovation in your workgroup.
Innovation: More Than a New Year's Resolution - This short e-book will help you defy complacency in your work and career.
The Six Core Values of Innovation - This short e-book describes the six core values, or contexts, of innovation.
A Major Mistake That Managers Make - Article by Russ Ackoff, Ph.D.
A Little Book off-Laws: 13 common sins of management - Article by Russ Ackoff, Ph.D.
Transforming the Systems Movement - Article by Russ Ackoff, Ph.D.
From Mechanistic to Social Systems Thinking - Article by Russ Ackoff, Ph.D.
Questionating - This short e-book will help you develop your skill in asking questions. It was W. Edwards Deming who said, "The questions are more important than the answers."
Nelson Mandela's Lessons of Leadership - Excellent article from Time
FDA Resources
Most recent are at the top
NovalisIntegra Close out Letter - Read this Close out letter issued by FDA after Warning Letter
Food Safety Tips for Healthy Holidays - FDA's guide published November 2009
ICH Q10 Pharmaceutical Quality System - Issued as a Guidance for Industry by FDA in April 2009
What FDA Does and Doesn't Regulate - This document clarifies what the FDA does and doesn't regulate
Sharfstein speaks on Supply Chain Safety Oct 2009 - Read a speech delivered by FDA Principal Deputy Commissioner Joshua Sharfstein, M.D. on Oct 22, 2009
Proposed GMP for Combination Products Sept 2009 - Read FDA's proposed new cGMP requirements for Combination Products
Sharfstein's comments Sept 2009 - Read comments from a speech delivered by FDA Principal Deputy Commissioner Joshua Sharfstein, M.D. “When public health is at stake, FDA is going to take this basic position: You can explain this problem to the public or we will.”
New England Journal of Medicine article June 2009 - Read this article by new FDA Commission Margaret Hamburg, M.D. and new FDA Principal Deputy Commissioner Joshua Sharfstein, M.D.outlining their vision for FDA
FDA's answer to Validation question Three Successful Batches? - Read this Q&A from FDA regarding the question of three successful batches to validate a process
FDA announces new policy for issuance of Warning Letters August 2009 - Read this Press Release with details of FDA's new policy on the issuance of Warning Letters
FDA Commissioner's Vision for Enforcement August 2009 - Read this speech delivered by FDA Commissioner Margaret Hamburg about her vision for enforcement
FDA Enforcement Statistics FY2008 - Chapter Ten from FDA booklet The Enforcement Story March 2009
FDA Glossary of Acronyms - Download your copy of FDA's acronyms
FDA Budget 2010 May 7, 2009 - Read FDA's Press Release describing their 19% budget increase request
FDA's Office of Criminal Investigations - Description of this office from FDA Consumer magazine
President Obama's Remarks about Food and Drug Safety and Nomination of New Commissioner - Read President Obama's speech of March 14, 2009 announcing the nomination of Dr. Hamburg for FDA Commissioner
Hamburg to Head FDA March 12, 2009 - News account indicating that Dr. Margaret A. Hamburg will be nominated to become FDA Commissioner
Cardinal Health 303 Inc. Amended Consent Decree February 2009 - Read this news account of why Cardinal Health 303 Inc. signed an amended Consent Decree with FDA over systemic issues in their operation
Cardinal Health Consent Decree February 2007 - Read this 27-page Consent Decree issued in 2007 for condemnation and permanent injunction
FDA's website on the peanut butter salmonella contamination issue - Visit FDA's website for up to date details
PCA's impact on small businesses February 28, 2009 - Read this news account of how the tainted peanut butter has caused small businesses (PCA's customers) to suffer
PCA's Texas plant FDA-483 report February 26, 2009 - Read this FDA-483 outlining deficiencies at PCA's Texas plant
PCA files for bankruptcy February 13, 2009 - Read this news report about PCA and their filing for bankruptcy
PCA owner appears before Congress and refuses to testify February 11, 2009 - Read this news report about PCA's owner and the Georgia plant manager, who both refused to answer questions at a Congressional hearing
PCA owner orders shipment of tainted products February 11, 2009 - Read this news account revealing internal e-mails where the company owner ordered shipments of salmonella contaminated products
Salmonella detected in Texas plan February 10, 2009 - Read this news account of the possible presence of salmonella at PCA's Texas plant
PCA shuts down plant in Texas February 10, 2009 - Read this news account on the Texas plant, which operated for four years unlicensed and uninspected by FDA and Texas health authorities
FBI raids PCA plant in Georgia February 9, 2009 - Read this news account of the FBI's raid on the plant at the core of the salmonella contamination
News report on the history of Peanut Corporation of America February 7, 2009 - Read this story on the history of problems this company has had with sanitation issues
Peanut Corporation of America Amended FDA 483 Report February 5, 2009 - Read this eight-page FDA 483 report, amended after FDA uncovered PCA knowingly shipped products contaminated with salmonella
Inspection Reports of PCA Plant February 1, 2009 - Read this news account of various inspections of Peanut Corporation of America's processing plant
FDA Opens Criminal Probe into Contaminated Peanut Products January 30, 2009 - Read this news account about the FDA and Dept. of Justice actions
Peanut Corporation of America FDA 483 Report January 27, 2009 - Read this six-page FDA 483 report issued regarding the peanut products contaminated with salmonella
FDA's new Commissioner's message January 21, 2009 - Frank Torti, M.D., MPH introductory message as FDA's Acting Commissioner
Good Importer Practices Guidance Document - Draft of new guidance for Good Importer Practices January 2009
FDA Acronyms - Glossary of FDA acronyms
Process Validation Guidance Document - Draft of FDA guidance on Process Validation: General Prinicples and Practices December 2008
Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals - Published in the Federal Register September 8, 2008, to go into effect December 8, 2008
FDA Presentation on Quality Program, CAPA and Audits - FDA's position on Quality Program, CAPA, and Audits
Laws Enforced by the FDA and Related Statutes - A listing of all the laws and statutes that the FDA enforces
Speech by FDA Commissioner Feb 29, 2008 - Read this speech entitled "FDA at a Turning Point: Meeting the Challenge of a Rapidly Changing World" byAndrew C. von Eschenbach, M.D.
Food Safety Tips for Healthy Holidays - FDA's Tips for Healthy Holidays
FDA Report - FDA Science and Mission at Risk November 2007 - Read this disturbing report commissioned by the FDA.
A Parent's Guide to Kids' Vaccines July 31, 2007 - FDA Consumer Health Information article
ICH Q10 Pharmaceutical Quality System guidance document, July 13, 2007 - Read this new guidance document available for public comment.
FDA Consumer Safety Office job description - Read the job description for an FDA Investigator (Consumer Safety Officer).
FDA presentation on ICH Q10- Presentation by FDA on ICH Q10 - Quality Systems
OOS Guidance Document - FDAGuidance for Industry issued October 12, 2006.
Quality Systems Approach to Pharmaceutical cGMP Regulations - Guidance document issued September29, 2006.
Implementing Quality Systems - PowerPoint presentation by Chris Joneckis, PhD FDACBER August 2006
Current Good Tissue Practice Regulation - FDA's regulation implemented in 2005.
FDA Manuals, Regulatory Publications, and Reports - A listing of all the FDA Manuals, Regulatory Publications, and Reports
Current Good Tissues Practice Guidance Document - FDA Guidance for Industry issued September 2006.
FDA Enforcement Report Aug 9,2006 - Selected excerpts from FDA's Enforcement Report highlighting GMP issues.
Small Business Guide to FDA - FDA's handbook for small business. Contains information about FDA's organization, procedures, policies, and regulations.
Human Drug CGMP Notes March 1999 - FDA's reference to Process Validation and "three consecutive batches"
FDA's Deputy Commissioner Speech, March 14, 2006 - Scott Gottlieb, MD, FDA's Deputy Commissioner for Medical and Scientific Affairs address at the 30th International Good Manufacturing Practices Conference at the University of Georgia College of Pharmacy
The Regulation of Dietary Supplements - Congressional testimony by the FDA Director of the Center for Food Safety and Applied Nutrition on March 9, 2006
FDA Enforcement Report February 1, 2006 - A sample of FDA's weekly Enforcement Report
Dispute Resolution Guidance - Formal Dispute Resolution: Scientificand Technical Issues Related to Pharmaceutical cGMP Guidance Document issued January 11, 2006
Centennial of the1906 Pure Food and Drugs Act - First in a series of articles in 2006 that will highlight some of the popular perceptions of the 1906 Pure Food and Drugs Act
FDA Recall Data for FY 2005 - CDER recalls in FY 2005, Top Ten reasons
Innovation or Stagnation - Important report issued by FDA in March 2004, and revised and updated in 2005.
Timely Resource Articles
Most recent are at top
FDA Enforcement Letters are UP! February 2010 - Read this news account about the steep increase in FDA Enforcement Letters.
U.S. Marshals Seize Unapproved Medical Devices January 2010 - Read this news account where the owner of a company denied FDA entry for an inspection
McNeil Consumer Healthcare Warning Letter January 2010 - Read this Warning Letter
Tylenol recall due to wooden pallets January 2010 - Read this news account of over 500 lots of product being recalled
McNeil Consumer Healthcare FDA-483 January 2010 - Read this FDA-483 Observation Report issued to McNeil Consumer Healthcare, makers of Tylenol
Won Feng Trading, Inc. Warning Letter issued May 2009 - Read this Warning Letter describing horrific conditions. FDA seized a $1 million of products on Jan 6, 2010
Pan American Labs Warning Letter November 2009 - Read this Warning Letter with a good description of "medical foods."
Genzyme contamination - Read this article about how FDA inspectors found bits of steel and rubber in injectable drugs November 2009
Genzyme Warning Letter - Read this Warning Letter issed to Genzyme Corp. in February 2009
FDA Tightens 510K Review Process Sept 2009 - Read this article outlining FDA's tighter approach to the 510K review process for medical devices
Washington Homeopathic Products, Inc. Warning Letter August 2009 - Read this Warning Letter issued after inadequate and/or no action taken after receiving an FDA-483 Observation Report
FDA Gets Tough August 2009 - Read this article from Newsweek
US Marshals Seize Contaminated Hand Sanitizer August 2009 - Read this article with details on the kind of trouble your company can face by not following cGMP
Advanced Neuromodulation Systems, Inc. Warning Letter June 2009 - Read this eight page Warning Letter. A good example of the lack of a systems approach to quality.
FDA files for Consent Decree against Quality Formulation Laboratories, Inc. (Dietary Supplement company) July 2009 - Read FDA's Press Release citing cGMP violations (including live and dead rodents) that led to a permanent injunction Consent Decree filing
Quality Formulation Laboratories FDA 483 Observations January 2009 - Read this eight-page FDA 483 issued to Quality Formulation Laboratories
Caraco announces layoffs July 2009 - Caraco Pharmecetucial Laboratories, Inc. lays off over half its work force due to GMP issues
U.S. Marshals Seize Drug Products at Caraco Pharmaceutical Laboratories, Ltd. June 2009 - Read FDA's Press Release and a news account of this action
Caraco Pharmaceutical Laboratories, Ltd. Warning Letter - Read this Warning Letter issued in October 2008
Nestle USA Refuses Access to FDA - Read this news article about Nestle's refusal to allow FDA to take photos and denial of access to certain documents
Howard Instruments, Inc. Warning Letter May 2009 - Read this eight page Warning Letter with details on the lack of training and training documentation
CheeriosTM Warning Letter May 2009 - Read this Warning Letter issued to General Mills regarding medical claims for CheeriosTM cereal
San Francisco Chronicle news account of P&G Warning Letter May 2009 - Read this news account from the San Francisco Chronicle about P&G's Warning Letter issued in Puerto Rico
Proctor and Gamble Warning Letter April 2009 - Read this Warning Letter issued to P&G's Puerto Rico facility
Duct Tape and Vendor Audits April 2009 - Read this news article with more lessons from the peanut butter salmonella case. This will make your jaw drop.
FDA Gearing Up for a More Activist Role April 2009 - Read this news story regarding a shift in the FDA.
Consent Decree for Neilgen Pharmaceuticals, Inc. and Advent Pharmaceuticals, Inc. April 2009 - Read FDA's Press Release announcing another Consent Decree
Consent Decree and Plant Shutdown March 2009 - Read FDA's Press Release announcing the shutdown of a tortilla manufacturer for GMP violations
Is FDA Broken? March 2009 - Read this news story regarding FDA which includes speculation on who may be the new FDA Commissioner
KV Pharmaceutical Co. Consent Decree March 2009 - Read FDA's Press Release about KV Pharmaceutical Co. Consent Decree
KV Pharmaceutical Co. FDA 483 Observation Report February 2009 - Read this 37 page FDA-483 Observation Report
AM2PAT Execs go to Prison - Feb 2009 - Read this story of how falsifying records gets two execs prison time
Canada quarantines Ranbaxy's products Feb 28, 2009 - Read this article about Health Canada placing a quarantine on Ranbaxy's products
Ranbaxy Labs falsifies data Feb 25, 2009 - Read FDA's Press Release where they found that Ranbaxy has falsified data and test results
FDA's letter to Ranbaxy Labs Feb 25, 2009 - Read FDA's letter to Ranbaxy Labs
India Business-Standard article about Ranbaxy Laboratories Sept 18, 2008 - Read this news account about Ranbaxy's financial performance and expected buy-out by a Japanese company
Forbes article about Ranbaxy Laboratories Sept 16, 2008 - Read this news account published in Forbes
Ranbaxy Laboratories Warning Letter #2 Sept 16, 2008 - Read this thirteen page Warning Letter issued to a second facility in India
Ranbaxy Laboratories Warning Letter Sept 16, 2008 - Read this seven page Warning Letter to a company based in India
Twelve arrested in Diethylene Gycol tainted medicine February 11, 2009 - Read this news account from Nigeria where 84 children died as a result of using this poisoned product
Brain Food, Wizard Oil, and other Nostrums Dec 16, 2008 - FREE graphics you can use in your GMP training
Obama to strengthen FDA Nov 6, 2008 - Read this news article about FDA in an Obama administration
Heparin seizure Nov 6, 2008 - Eleven lots of contaminated heparin seized by U.S. marshals from Celsus Laboratories, Inc. in Cincinnati
GAO Report issued Oct 22, 2008 - Read the Government Accountability Office's 53-page report, "Drug Safety: Better Data Management and More Inspections Are Needed to Strengthen FDA's Foreign Drug Inspection Program"
News articles about GAO Report Oct 22, 2008 - Read these news reports about the GAO report condemning FDA's ability to monitor foreign drug manufacturers
NeoChild LLC Warning Letter July 29, 2008
- Read this eight page Warning Letter detailing ineffective responses to a FDA 483 Notice of Observations
Volk Optical, Inc. Warning Letter July 7, 2008 - Read this five page Warning Letter
Carematix Inc. Warning Letter July 3, 2008 - Read this eight page Warning Letter
Anika Therapeutics, Inc Warning Letter July 2, 2008 - Read this nine page Warning Letter
Written Procedures and the Incoming Workforce - A list of interesting facts regarding those entering the workforce in 2008. An example: They grew up with digital clocks. Half past three or quarter to four may have no meaning to them.
Keep your GMP Training ALIVE! Table Topper example - June 15, 2008 - Here's an example of a Table Topper you can use in Keeping Your GMP Training Alive
FDA Staff in Crisis - June 8, 2008 - Read this news account of FDA staffers leaving the FDA, where the average age is 54
Warning Letters Drop in Number June 6, 2008 - Read this news report about the Enforcement Shift at FDA
Scientific Laboratories Inc. Consent Decree May 16, 2008- Read this Press Release from FDA announcing the Consent Decree signed by Scientific Laboratories Inc.
Merck Warning Letter April 28, 2008- Read this nine page Warning Letter issued to Merck and Company, Inc.
National Biological Corp. Warning Letter April 23, 2008 - Read this Warning Letter dealing with customer complaint handling and caPA (Corrective and Preventive Action)
Trying Times at the FDA: The Challenge of Ensuring Safety of Imported Pharmaceuticals April 24, 2008 - New England Journal of Medicine article
The Heparin Fiasco April 10, 2008 - Read this New York Times story with details
Philips Lifeline, Inc. Warning Letter February 29, 2008 - Read this Warning Letter issued to a Medical Device manufacturer
Testimony of Sidney Wolfe, M.D. before Congress February 27, 2008 - Read Dr. Wolfe's testimony citing a crisis in leadership in the FDA.
Baxter's explanation of the heparin incident Feb 19, 2008 - Read Baxter's explanation about the heparin incident.
FDA Mixed-up Drug Plant Names in China Feb 19, 2008 - Read this news article about FDA's mix-up and Baxter's troubles with heparin, a blood thinner.
Congressman Calls for FDA Commissioner to Resign Feb 15, 2008 - Read this news account about FDA getting blamed by a Congressman for recent problems.
Red Cross announcement of fine - February 7, 2008 - Read The Red Cross' announcement regarding the new fine.
FDA Fines Red Cross $4.6M February 7, 2008 - FDA assesses another fine on the American Red Cross for distribution of unsuitable blood products. Fines in recent years now total more than $19 million.
Vintage Pharmaceuticals, LLC Warning Letter February 1, 2008 - Read this Warning Letter issued because of an inadequate response to a Form FDA 483, List of Inspectional Observations.
Recall Notice of Contaminated Syringes January 18, 2008 - Heparin and Saline pre-filled flushes recalled due to bacterial contamination.
Noven Pharmaceuticals, Inc. Warning Letter January 4, 2008 -Read this Warning Letter issued because of an inadequate response to a Form FDA 483, List of Inspectional Observations.
G. Dundas and Company, Inc. Warning Letter December 13, 2007 - Read this Warning Letter issued because of an inadequate response to a Form FDA 483, List of Inspectional Observations.
Dirty Tank Leads to Contaminated Products - Read this news account of an API manufacturer who hadn't cleaned a holding tank with a key starting raw material in years, and how it led to several batches of product getting contaminated.
China Gets Serious on GMP - China's State FDA is ramping up its enforcement of GMP, working with US FDA on safety pact.
FDA Damned If It Does, Damned If It Doesn't - An interesting article published in Fortune about FDA's current strategies.
Med-South Pharmacy Inc. Warning Letter - An interesting look at drugs compounded by local pharmacies. Read FDA's comments on how these drugs are regulated.This is a good case study demonstrating the "c" in cGMP - keeping current with the ever evolving GMP regulation.
Tylenol is Different ad campaign - Look at Tylenol's new advertising campaign "Tylenol is different because of the people who make it."
Contaminated beef leads to company shutdown October 5, 2007 - Beef processor forced to recall one year's production and calls it quits
Proctor & Gamble Warning Letter September 14, 2007 - Read this Warning Letter detailing the difference between a sanitizer and a drug.
Swanson Health Products Inc.Warning Letter August 8, 2007 - Read this Warning Letter to a North Dakota company detailing the fine line between a Dietary Supplement and a Drug.
Sunburst Biorganics Warning Letter August 7, 2007 - Read this Warning Letterto a New York company detailing the fine line between a Dietary Supplement and a Drug.
AIDS drug recalled July 23, 2007 - Read this article from the New York Times detailing the impact on poor people in developing nations of this contaminated AIDS drug.
Chinese FDA Chief executed July 10, 2007 - Read this startling article on China's former head of their FDA executed for taking bribes.
Shelhigh Consent Decree June 22, 2007 - Read FDA's Press Release announcing this consent decree for a manufacturer of heart valves.
Imported Generic Drugs on the Rise June 17, 2007 - Read this Washington Post story about the increase in generic drugs from India and China and FDA's challenge in inspecting plants in these two countries.
Crystal Reflections International Warning Letter June 14, 2007
- Read thisWarning Letter issued to a manufacturer of contact lenses. The change control system consisted of "post-it" notes!
Taste of Raspberries, Taste of Death - Read this chilling account of the 1937 Elixir of Sulfanilamide tragedy
Chinese toothpaste advisory June1, 2007 - Read FDA's advisory to avoid toothpaste containing diethylene glycol made in China.
Advanced Medical Optics Recall of Contact Lens Solution May 25, 2007 - Read FDA's announcement of Advanced Medical Optics' recall of one of their contact lens solutions.
Advanced Medical Optics recall notice November 21, 2006 - Read this recall notice of a contact lens solution - contaminated batches
FDA Plans to Close Labs - Read this story from McClatchy Newspapers on this controversial plan by FDA to close and consolidate their laboratories May 2007
Senate debates bill to increase power and money for FDA - Read this story from The New York Times May 2007
FDA Comes Under Fire -AGAIN! - Read this story from the Washington Post April 2007
Abbott Laboratories, Inc. Warning Letter - Issued to Abbott Diagnostics Division in March 2007
Abbott Consent Decree -Read this landmark twenty-four page Consent Decree issued in 1999
Fisher and Paykel Healthcare Inc. Warning Letter - Issued February 2007
Medical Concepts Development Warning Letter - Issued February 2007
Niagara Pharmaceuticals Inc. Warning Letter - Issued February 2007
Rymed Technologies Inc. Warning Letter- Issued February 2007
First Check Diagnostics, LLC Warning Letter - Issued February 2007
GE Healthcare Technologies Warning Letter- Issued February 2007
Actavis Totowa, LLC Warning Letter -Issued February 2007
Edwards Life Sciences Warning Letter - Read this eight page Warning Letter issued inFebruary 2007
Cardinal Health Consent Decree - Read this 27-page Consent Decree for condemnationand permanent injunction.
FDA's announcement of Cardinal Health Consent Decree - Read FDA's reasons for obtaining this consent decree for condemnation and permanent injunction against Cardinal Health.
Whistleblowers Help Congress Strengthen FDA - Read this February 2007 article.
The Birth of CGMPs - Read this article by FDA Historian Dr. Suzanne White Junod about the beginnings of the CGMP regulation.
News account of GE OEC Medical Systems problems - Read this newspaper account about the problems facing this company.
GE OEC Medical Systems Warning Letter - Read this Warning Letter issued in March 2005.
GE OEC Medical Systems Consent Decree announcement - Read FDA's Press Release January 12, 2007 announcing this Consent Decree.
New Congress to Split FDA?- Published January 7, 2007. An article speculating that the new Democrat controlled Congress will split FDA into two agencies, one for the Foods industry, and one for the Medical industries.
Why Drug Prices are High - An informative article by syndicated columnist Jay Ambrose published December 11, 2006.
Boston Globe news article - Read this analysis of the impact of the November election and FDA as well as an analysis of FDA's action plan for Medical Device Post Market Monitoring
FDA Press Release - Medical Device Post Market Monitoring - Nov 9, 2006 - FDA's action plan for strengthening the way it monitors the safety of medical devices after they reach the marketplace.
Perrigo recalls acetominophen Nov 9,2006 - News story detailing recall of 11 million containers of acetominophen for metal fragments
Bausch and Lomb Warning Letter Oct 31, 2006 - Read this eleven page Warning Letter outlining systemic violations
Bausch and Lomb FDA 483 May 2006 - Read this eleven page FDA 483. Bausch and Lombissued a recall of one of their products the day after receiving this 483.
FDA Newsletter from November 1962 - Historic photos of President Kennedy upon the advent of GMP
GSK recalls Paxil - Missing Active Ingredient - October 5, 2006 news article
Graham's editorial published by JAMA - Dr. David J. Graham's editorial published by the Journal of the American Medical Association.
USA Today Sept 12, 2006 -Dr. Graham Speaks Out - Read this article where FDA official Dr .David J. Graham speaks out about new arthritis drugs.
American Red Cross fined by FDA September 8, 2006 - Read this Press Release from FDA explaining why the American Red Cross was fined $4.2 million for violating GMP regulations.
Command Medical Products Warning Letter August 17, 2006 - Read this short Warning Letter and gain insights into FDA's thinking.
FDA Commissioner Nomination Embroiled in Politics - Read this article published the day after the Senate held confirmation hearings on Andrew von Eschenbach's nomination as FDA's Commissioner.
FDA Q&A regarding Sanofi Pasteur Warning Letter - Gain valuable insights into FDA's thinking by reading this Question and Answer document released by FDA on July 3, 2006
Sanofi Pasteur Warning Letter June 30, 2006 - Read this seven page Warning Letter.
Sanofi Pasteur FDA 483 April 2006 - Read this eight page FDA 483.
Rep. Waxman's statement June 27, 2006 - Statement upon release of Prescription for Harm report
Prescription for Harm: The Decline in FDA's Enforcement Activity - Congressional report issued June 27, 2006 by Rep. Henry Waxman
How Theodore Roosevelt Made Your Dinner Safe to Eat - Read this fascinating article published in American Heritage Magazine on June 29,2006
Protecting America's Health - Read this review of Philip J. Hilts' book, Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation.
Centennial of The Jungle - Read this fascinating story published on May 31, 2006 about the intricacies of how the landmark book, The Jungle by Upton Sinclair, led to the Pure Food and Drugs Act of 1906.
Executives convicted May 3, 2006 - FDA's Press Release with details
FDA Cease Manufacturing Letter Jan 31, 2006 - FDA's letter to Biomedical Tissue Services Ltd
Schering-Plough's Consent Decree - Read this 46 page Consent Decree issued in May 2002 to Schering-Plough Corporation
Guidant Corp. Warning Letter Dec 2005 - Read FDA's Warning Letter as a follow-up to the Sept 2005 FDA 483
Guidant Corp. FDA 483 Sept 2005 - Read this seven page FDA 483 with fifteen major observations
Google's Ten Golden Rules Dec 2, 2005 - Newsweek article describing how Google manages "knowledge workers"
FDA Issues Consent Decree to MBI Nov 29, 2005 - Read FDA's Press Release
US Marshals seize infusion pumps, Oct 12, 2005 - FDA and US District Court work together to seize products manufactured by Baxter Healthcare Corp.
Jury Award in Vioxx Trial - August 18, 2005 - First jury award against Merck
Pharmakon Labs Shut Down July 27, 2005 - Read FDA's Press Release
Able Laboratories FDA 483 July 2005 -Read this fifteen page FDA 483 with twelve major observations.
Able Labs in USA Today July 12,2005 - Read this interesting story published in USA Today.
Continuous Improvement under Modern Quality Systems and cGMPs - FDA's Richard Friedman's presentation at the 2005 Drug Information Association meeting, June 26 -30 Washington DC
cGMP for Dietary Supplements
FDA Guidance - Adverse Event Reporting and Recordkeeping June 2009 - FDA's new guidance
cGMP for Dietary Supplements Final Rule June 22, 2007 - FDA's Preamble and Final Rule to the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
cGMP for Dietary Supplements 21CFR Part 111 - Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
FDA Press Release announcing cGMP for Dietary Supplements June 22, 2007 - FDA's Press Release
FDA's Background info on cGMP for Dietary Supplements June 22, 2007 - FDA's Backgrounder document
FDA Consumer article on new Safe Use of Dietary Supplements June 22, 2007 - FDA Consumer Health Information article
Definition of Adulteration- Section 402 of the Federal Food, Drug, and Cosmetics Act
cGMP for PET Drugs
On September 19, 2005, FDA proposed cGMPs for Positron Emission Tomography (PET) Drug Products.
FDA's Press Release - Read FDA's announcement here.
cGMP for PET Drug Products Guidance Document - Read the Guidance Document here.
FDA's Questions and Answers- Read FDA's Questions and Answers regarding the proposed cGMPs.
INDs - CGMPs During Phase I Clinical Trials
In January 2006, FDA proposed a controversial change to CGMP
compliance during Phase I clinical trials. FDA withdrew the rule on May 1.
INDs - Approaches to Complying with CGMP During Phase I Guidance Document - Read the Guidance Document here.
Proposed Rule - Read the announcement published in the Federal Register.
Direct Final Rule - Read the announcement published in the Federal Register.
Rule Withdrawal- Read FDA's announcement of May 1, 2006 withdrawing this controversial change.
Medical Gases
FDA Press Release April 10, 2006 - Read this Press Release detailing FDA's new proposed rule for Medical Gases
FDA's Questions and Answers - Read FDA's Questions and Answers regarding the new proposed rule
Medical Gas cGMP- 21 CFR Parts 201 and 211, Medical Gas Containers and Closures; Current Good Manufacturing Requirements (draft guidance)
Medical Devices
FDA Press Release May 22, 2006 - Initiative to Facilitate the Development and Availability of Medical Devices
Medical Device Initiative May 2006 - Medical Device Innovation Initiative
Draft Guidance May 2006 - Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials: Draft Guidance for Industry and FDA Staff
Inspection of Medical Device Manufacturers June 2006 - Guidance document issued by FDA on June 15, 2006
