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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 […]
November 30, 2020

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

Drug Development Tools (DDTs) are methods, materials, or measures that have the potential to facilitate drug development. As described in the 21st Century Cures legislation, DDTs […]
November 27, 2020

FDA approves device for treatment of osteoid osteoma in the extremities

On November 27, 2020, the Food and Drug Administration approved the Sonalleve MR-HIFU system (Profound Medical Inc.) for the treatment of osteoid osteoma in the extremities. […]
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