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Biologics

FDA/CDC Correct Florida Officials Vaccine Misinformation

FDA and CDC send a letter to Florida surgeon general Joseph Ladapo to correct his misinterpretations and misinformation about Covid-19-related data.

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FDA General

FDA Webview Reaches Out for Your Guidance

Still evolving under the same leadership, Dickinsons FDA Webview asks subscribers to help guide our further development and improve service.

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Medical Devices

FDA Clears PeekMed Orthopedic Surgery Planner

FDA clears a PeekMed 510(k) for its Web-based artificial intelligence automated planning solution for use in orthopedic surgery.

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Human Drugs

Most Drug Shortages are Manufacturing Related: FDA

FDA says the main causes of drug shortages continue to be manufacturing quality issues and manufacturing production delays.

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Federal Register

Panel to Review Entasis Therapeutics NDA

Federal Register notice: FDA announces a 4/17 Antimicrobial Drugs Advisory Committee meeting to discuss an Entasis Therapeutics NDA for sulbactam-durl...

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Human Drugs

GAO Report Hits FDA on Advanced Manufacturing Tracking

A new Government Accountability Office report recommends that FDA better track the extent of its efforts to encourage drug manufacturers to adopt adva...

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FDA Outlines Disposition of Covid-19 Guidances

FDA publishes a Federal Register notice outlining the status of the many guidance documents that were issued to address the Covid-19 public health eme...

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Human Drugs

FDA Divides into Two its Guide on Face Masks

FDA splits into two its guidance entitled Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators Dur...

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Human Drugs

Pfizer NDA for Migraine Nasal Spray OKd

FDA approves a Pfizer NDA for Zavzpret (zavegepant), the first calcitonin gene-related peptide receptor antagonist nasal spray for treating adults wit...

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Medical Devices

18 Senators Want End to Accelerated Approval Pricing Model

A letter from 18 Republican senators urges HHS to abandon a Medicare pricing model that aims to balance incentives for developing novel treatments und...