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FDA publishes a draft guidance aimed at increasing the enrollment of females in clinical trials of drugs and medical devices.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

Sanofi Scraps Tolebrutinib MS Filing after Phase 3 Miss

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Sanofi says it will not seek FDA approval for tolebrutinib in primary progressive multiple sclerosis after the drug failed to meet...

Restrictions on Real-World Evidence Regulatory Reviews Eased

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FDA says it is removing a long-standing barrier to the use of real-world evidence in regulatory reviews by accepting such data wit...

2 Guides Posted on Product Safety Reporting

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FDA posts two final guidances that provide recommendations to help clinical investigators comply with the safety reporting require...

GAO Flags Staffing Gaps and Legal Limits With Device Recalls

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The Government Accountability Office urges HHS to shore up staffing and reassess legal authorities at FDA after finding significan...

FDA OKs Enhertu Combo as First-Line for Advanced Breast Cancer

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FDA approves Daiichi Sankyos Enhertu (fam-trastuzumab deruxtecan-nxki) in combination with Genentechs pertuzumab as a first-line t...