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Gottlieb Hits Federal Corona Virus Lack of Urgency

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Former FDA commissioner Scott Gottlieb says the federal government was late in bringing academic and private laboratories into the...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Guangzhou Tinci Materials Technology and James R. Corbett.

FDA Eliminates CV Outcomes Data on Diabetes Drugs

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FDA issues a new draft guidance on Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control tha...

Mylan/Biocon BLA for Avastin Biosimilar

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FDA accepts for review a Mylan/Biocon BLA for MYL-1402O, a biosimilar candidate referencing Genentechs Avastin (bevacizumab).

Public Meeting on FDA/Health Canada ICH Activities

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FDA announces a 4/3 public meeting entitled U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on the...

FDA OKs Ofev for Lung Disease Scarring

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FDA approves Boehringer Ingelheim Pharmaceuticals Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing interst...

Info Collection on Safety Communication Survey

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Federal Register notice: FDA seeks comments on an information collection extension for FDA Safety Communication Readership Survey....

Hahn says 1.1 Million Coronavirus Tests Shipped

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FDA commissioner Stephen Hahn says that 1.1 million more coronavirus tests have just been shipped by nonpublic health labs.

Guide on Electrosurgical Device 510(k)s

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FDA issues a final guidance on 510(k) submissions for electrosurgical devices.

Warning Letters Sent Over Unapproved Virus Products

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FDA and FTC have issue seven Warning Letters to companies for allegedly selling fraudulent coronavirus products.