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Significant CGMP Violations at World Perfumes

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FDA warns Opa-Locka, FL-based World Perfumes about CGMP violations in its production of finished drugs as a contract manufacturer.

FDA, Patent Office at Odds on Biosimilars: CBS News Report

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CBS News says the federal patent office is taking steps to slow challenges to innovator biologic drug patents by biosimilar drug m...

FDA Needs More Data on China Drug Production: Report

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A congressional commission on U.S.-China relations calls on Congress to authorize FDA to collect data from drug companies on where...

Petition Rejected on New Warnings for Surgical Mesh

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FDA denies a citizen petition requesting that it warn patients about whether surgical mesh implanted off-label during cosmetic mas...

Multiple Violations in DermaRite Inspection

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FDA warns North Bergen, NJ-based DermaRite Industries about CGMP, unapproved new drug, and misbranded drug violations in its produ...

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...