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December 1, 2020

Rare Diseases Program

Mission Statement: To facilitate, support and accelerate the development of drug and biologic products for the benefit of patients with rare disorders. Overview: Coordinate the development […]
December 1, 2020

FDA approves pralsetinib for RET-altered thyroid cancers

On December 1, 2020, the Food and Drug Administration approved pralsetinib (GAVRETO, Blueprint Medicines Corporation) for adult and pediatric patients 12 years of age and older […]
December 1, 2020

Industry Information and Guidance

Biological products are the fastest growing class of therapeutic products in the United States and account for a substantial and increasing portion of health care costs. […]
December 1, 2020

Avazo-Healthcare, LLC – 610282 – 11/30/2020

Product: DrugsMedical Devices WARNING LETTER Date:     November 30, 2020 TO: 605 Louis Dr Ste 502Warminster, PA 18974 CBD Market Web605 Louis Dr Ste 02Warminster, PA […]
December 1, 2020

West Coast Nuclear Pharmacy – 604169 – 10/06/2020

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Warren C. Gray Recipient Title President West Coast Nuclear Pharmacy 3906 Cragmont DriveTampa, FL 33619United States […]
December 1, 2020

World AIDS Day 2020: FDA Continues to Drive Advances in Care and Work with the Global Public Health Community

Image CaptionLeft to right: the first FDA-approved AIDS drug Retrovir (Zidovudine), the AIDS quilt being assembled on the National Mall in 1987, and an assortment of […]
November 30, 2020

FDA Announces 4 Grant Awards for Projects Exploring the Use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making

As part of the agency’s real-world evidence (RWE) efforts, the U.S. Food and Drug Administration is announcing four grant awards (RFA-FD-20-020) to examine the use of real-world […]
November 30, 2020

Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program Submission Process

Submission Process The 21st Century Cures Act formally established a multi-step process for Drug Development Tools (DDT) qualification. Qualification of a DDT is for a specific […]
November 30, 2020

Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry

Submit Comments by 02/26/2021 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
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