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Make UDI Publicly Available in Databases: Petition

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Ombu Enterprises petitions FDA to make unique device identifier information publicly available in the MAUDE and Recall databases.

Senators Urge FDA: Do More to Resolve Drug Shortages

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A bipartisan Senate letter urges FDA commissioner Robert Califf and HHS secretary Xavier Becerra to step up efforts to help resolv...

FDA Grants, Denies Parts of Microbiome Petition

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FDA grants one part and denies another part of a petition submitted by the Microbiome Therapeutic Innovation Group by publishing a...

Regeneron Files sBLA for Evkeeza in Young Children

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FDA accepts for priority review a Regeneron Pharmaceuticals supplemental BLA for Evkeeza (evinacumab-dgnb) as an adjunct to other ...

Voting Members Sought for Radiation Safety Panel

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Federal Register notice: FDA requests nominations for voting members to serve on CDRHs Technical Electronic Product Radiation Safe...

Draft Guide on Heartworm Drugs for Dogs

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Federal Register notice: FDA makes available draft guidance #276 entitled Effectiveness of Anthelmintics: Specific Recommendations...

2 Admit Role in $38 Million Compounding Fraud

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The Justice Department says the two owners of New Jersey-based Synergy Medical have admitted to participating in a conspiracy to c...

Congress Should Pass VALID Act on LDTs: Advocates

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The heads of two cancer advocacy organizations urge Congress to approve the VALID Act to regulate laboratory-developed tests offer...

Janssen Sues Amgen Over Stelara Biosimilar Plans

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Janssen files a patent infringement suit against Amgen and its plans to seek FDA approval and market a biosimilar copy of Janssens...

Merck in Keytruda Patent Dispute with Johns Hopkins

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Merck sues Johns Hopkins University in Maryland federal court over patents Hopkins obtained following a research collaboration wit...