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Panel to Discuss Teva BLA for Asthma

[ Price : $8.95]

Federal Register Notice: FDAs Pulmonary-Allergy Drugs Advisory Committee will meet 12/9 to discuss a Teva Pharmaceutical BLA to im...

Nominations Sought for Device Patient Engagement Panel

[ Price : $8.95]

Federal Register Notice: FDA requests nominations for members to serve on the CDRH Patient Engagement Advisory Committee.

Inrange Petitions FDA to Act Against Unapproved Device

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Inrange Systems petitions FDA asking that it detain a competitors product because it is allegedly not cleared or approved for sale...

FDA to Post Consumer Docket Comments on Regulations.gov

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FDA says it is changing longstanding practice of not publically posting public docket comments from individual consumers on the go...

FDA Accepts NDA Resubmission for Sustol

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FDA accepts for review a Heron Therapeutics NDA resubmission for Sustol (granisetron) injection extended release, indicated for pr...

FDA Revises Pradaxa Bioequivalence Guidance

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FDA revises a draft guidance on how to demonstrate the bioequivalence of generic versions of Boehringer Ingelheim Pharmaceuticals ...

More Biosimilar Guidance Forthcoming: Woodcock

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CDER director Janet Woodcock tells a Senate hearing that the Center is planning to release three biosimilar-related guidances in t...

New Patient Engagement Advisory Panel for Devices

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Recognizing the importance of patient input on regulatory issues, FDA establishes a Patient Engagement Advisory Committee, which w...

SynCardia Systems Class 1 Recall for Heart Device

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SynCardia Systems begins a Class 1 recall of its Freedom Driver System because a part may fail causing the device to stop working.

FDA Grants QIDP Designation to Cempra Antibiotic

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FDA grants a qualified infectious disease product designation to Cempra, Inc. for its investigational antibiotic Taksta for treati...