GMP Tips

In a surprise announcement on September 23, FDA Commissioner Dr. Lester Crawford, just confirmed in July, announced his immediate resignation. The revolving door to the Commissioner’s office keeps spinning. Here’s a brief history. David Kessler 1990 – 1997 Lester Crawford 1997 – 1999 Acting Commissioner Jane Henney 1999 – 2001 (2 years) Lester Crawford 2001 [...]

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The Food and Drug Administration (FDA) just announced a proposed current good manufacturing practices (CGMP) regulation for the production of Positron Emission Tomography (PET) drugs. Positron emision tomography is a medical imaging modality involving the use of radiopharmaceutical drug products. The majority of PET drug products are injected intravenously into patients for diagnostic purposes. Most [...]

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