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April 13, 2020

Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products

Docket Number: FDA-2018-D-3380 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research Office of Medical Products and Tobacco, […]
April 13, 2020

Product-Specific Guidances for Chloroquine Phosphate and Hydroxychloroquine Sulfate

Docket Number: FDA-2007-D-0369 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research The Food and Drug Administration (FDA […]
April 13, 2020

FDA approves selumetinib for neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas

On April 10, 2020, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca) for pediatric patients, 2 years of age and older, with neurofibromatosis type 1 […]
April 13, 2020

Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee) Roster

Applying for Membership on FDA Advisory Committees As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of […]
April 10, 2020

How You Can Make a Difference During the Coronavirus Pandemic

Image The COVID-19 pandemic has created challenges in our everyday lives. As we each do our part to help slow the spread of coronavirus disease, we […]
April 10, 2020

Q4B Annex 8: Sterility Test General Chapter

Docket Number: FDA-2009-D-0013 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 10, 2020

Q4B Annex 7 (R2): Dissolution Test General Chapter

Docket Number: FDA-2009-D-0012 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 10, 2020

Q4B Annex 6: Uniformity of Dosage Units General Chapter

Docket Number: FDA-2009-D-0011 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 10, 2020

Q4B Annex 5: Disintegration Test General Chapter

Docket Number: FDA-2008-D-0399 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
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