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FDA Generic User Fee Negotiations Offer Proposals

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FDA and generic drug manufacturers kick off formal negotiations on the next cycle of the Generic Drug User Fee Amendments during a...

Former FDA CMC Reviewer Joins Law Firm

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Former CDER chemistry, manufacturing and controls (CMC) reviewer Fabiola Cervantes-Gomez joins Hyman, Phelps & McNamaras as a CMC ...

Group Seeks Stronger Pregnancy Warning on Antidepressants

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Advocacy group Public Citizen petitions FDA to add new, class-wide pregnancy warnings to the labels of commonly prescribed seroton...

FDA Flags AstraZenecas Farxiga TV Ad as Misleading

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FDA cites a direct-to-consumer television advertisement for AstraZenecas Farxiga (dapagliflozin) tablets.

Hims & Hers Names Ex-FDAer Autor as Chief Policy Officer

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Hims & Hers Health appoints former FDA Global Regulatory Operations and Policy deputy commissioner Deb Autor as its first chief po...

NIH Grant Cuts Disrupt Hundreds of Clinical Trials: JAMA

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A new JAMA research letter finds that more than 380 clinical trials supported by the NIH lost funding this year affecting about 1...

RFK Jr. reportedly Mulled Limiting Makarys Authority

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HHS secretary Robert F. Kennedy Jr. reviews options to scale back the operational role of FDA commissioner Marty Makary, including...

Promising Ziihera Data in Gastric Cancer Trial

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Zymeworks reports that its HER2-targeted bispecific antibody Ziihera (zanidatamab-hrii) significantly improved outcomes for patien...

Aseptic Breakdowns at Sanofis Fill-Finish Plant: FDA

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FDA posts a Form 483 that cites significant lapses in aseptic manufacturing practices at Sanofis sterile drug-product facility in ...

Guide on PH Waivers for Certain Generics

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FDA posts a final guidance entitled Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Pare...