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Organon Backs FDA Biosim Label Change

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Organon says it agrees with an FDA policy change to have a biosimilar statement accompany both biosimilars and interchangeables.

Democrats Introduce Anti Pay-for-Delay Bill

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Reps. Marie Gluesenkamp Perez (D-WA), Sean Casten (D-IL), and Gerry Connolly (D-VA) introduce a bill to ban brand companies from e...

Guide on Real-Time Oncology Reviews

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Federal Register notice: FDA makes available a guidance entitled Real-Time Oncology Review (RTOR).

14 Observations in Kilitch India FDA-483

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FDA releases the form FDA-483 with 14 observations from an inspection at the Kilitch Healthcare India sterile drug manufacturing f...

FDA Proposes to Withdraw Carbadox Approval

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Federal Register notice: FDA proposes to withdraw approval of Phibro Animal Healths NADAs for carbadox in medicated swine feed.

Improve Cell, Gene Manufacturing Guidance: ISCT

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The International Society for Cell & Gene Therapy suggests ways to improve an FDA draft guidance on manufacturing changes and comp...

FTC Challenges Patent Listings in Orange Book

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In a major move against questionable drug patents, the FTC challenges the legitimacy of more than 100 patents listed in FDAs Orang...

Law Blog Faults FDA on Remote Evaluations

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Two Hyman, Phelps & McNamara staff say FDA missed an opportunity to conduct many remote interactive evaluations of drug manufactur...

Neurotris Illegally Marketing Devices: FDA

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FDA warns Irvine, CA-based Neurotris about multiple violations in its illegal manufacturing and distribution of muscle stimulator ...

Real-Time Oncology Review Guidance

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FDA publishes a guidance with recommendations for select NDAs and BLAs submitted for Real-Time Oncology Review.