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Califf in Hot Seat at 4/11 Oversight Hearing

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The House Committee on Oversight and Accountability ratchets up political pressure on FDA by requesting commissioner Robert Califf...

Amylyx Pulls ALS Drug From the Market

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Amylyx Pharmaceuticals withdraws the approval of its amyotrophic lateral sclerosis drug Relyvrio (sodium phenylbutyrate and taurur...

Guide on Dietary Supplement Master Files

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Federal Register notice: FDA makes available a draft guidance entitled New Dietary Ingredient Notification Master Files for Dietar...

Smiths Medical Recalls PneuPac Ventilator Kits

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Smiths Medical recalls its PneuPac paraPAC Plus 300 and 310 Ventilator Kits after receiving reports that the device may malfunctio...

Ignore Former FDAers Comments: Sidley

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A Sidley petition comment response asks FDA to disregard comments on Sidleys orphan drug exclusivity petition made by former FDA o...

New Indication for Vandas Fanapt

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FDA approves a new indication for Vandas Fanapt to treat some adults with bipolar I disorder.

Bipartisan Bill on Drug-Gene Interactions

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Representatives Eric Swalwell (D-CA) and Dan Crenshaw (R-TX) introduce bipartisan legislation to help address drug-gene interactio...

Contract Pharma Cited on Environmental Issue

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FDA sends Contract Pharmaceuticals Limited a Form FDA-483 citing one observation after its Mississauga, Canada facility was inspec...

Guide on Bioequivalence Study Data Integrity

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Federal Register notice: FDA makes available a draft guidance entitled Data Integrity for In Vivo Bioavailability and Bioequivalen...

HHS Defines FDA Roles in Drug Shortages

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A new HHS white paper on drug shortage policies cites many steps FDA has taken and wants to take in the future.