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Republicans Dismiss RFK Jr. Subpoena Vote for Testimony

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House Energy and Commerce Committee Republicans blocked an effort by Democrats to compel HHS secretary Robert F. Kennedy Jr. to te...

Sen. Johnson Seeks FDA Docs on Covid Vaccine Deaths

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Sen. Ron Johnson (R-WI) demands that FDA turn over records related to an internal review that linked Covid-19 vaccinations to the ...

Medical Device RWE Guidance

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FDA publishes a guidance clarifying how it evaluates real-world data to determine if they are sufficient to provide real-world evi...

Merck Cholesterol, Cancer Drugs Added to Voucher Program

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FDA selects investigational cholesterol and cancer drugs from Merck for expedited regulatory reviews under its Commissioner's Nati...

3D Imaging CGMP and Listing Violations

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FDA warns Little Rock, AR-based 3D Imaging Drug Design and Development about CGMP and listing violations in its production of posi...

FDA Extends Review Timeline for Aldeyras Dry Eye Drug

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FDA extends the review of Aldeyra Therapeutics NDA resubmission for reproxalap, pushing back a regulatory decision on the investig...

Guide to Increase Female Enrollment in Trials

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FDA publishes a draft guidance aimed at increasing the enrollment of females in clinical trials of drugs and medical devices.

Trump Taps Controversial Figure to Lead Cancer Panel

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President Trump appoints Yale epidemiologist Harvey Risch to chair the Presidents Cancer Panel, a move that is raising alarm among...

7 Observations on ProRx FDA-483

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FDA releases the form FDA-483 with seven observations from an inspection at the Exton, PA-based ProRx outsourcing facility.

Microvascular Tissue Marketing Unapproved New Drug

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FDA warns San Diego, CA-based Microvascular Tissue about CGMP violations in its production and marketing of an unapproved new drug...