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Human Drugs

NDRP Modernization Successes Lead to Permanent Initiative

CDER Office of New Drugs Special Program Staff associate director Yoni Tyberg discusses the New Drug Regulatory Program modernization and its successe...

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Medical Devices

AdvaMed Concerned with Device Remanufacturing Guide

Advanced Medical Technology Association says there are inconsistencies and ongoing concerns with FDAs guidance on remanufacturing/servicing medical de...

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Human Drugs

Regeneron Urges New Guidances for Precision Medicine

Regeneron calls on FDA to develop two guidances to further the use of precision medicine in non-oncology diseases.

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Human Drugs

Glenmark Pharma Recalls Potassium Chloride

Glenmark Pharmaceuticals recalls (Class 1) 114 batches of potassium chloride extended-release capsules, USP (750 mg), due to dissolution concerns.

Biologics

Biden Pressured FDA for Pfizer Covid Vaccine: House Report

A House subcommittee report claims that FDA cut corners in its usually rigorous processes and bowed to Biden Administration political pressure in appr...

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Human Drugs

2nd Complete Response on AbbVie Parkinsons Drug

FDA sends AbbVie a second complete response letter on its NDA for ABBV-951 (for carbidopa/foslevodopa) for treating motor fluctuations in adults with ...

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Federal Register

Guide on Lab-Developed Test Compliance Guide

Federal Register notice: FDA makes available a final guidance entitled Laboratory Developed Tests (LDTs): Small Entity Compliance Guide.

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Human Drugs

Rexulti/Sertraline Combo NDA for PTSD

FDA accepts for review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) in combination with sertraline for treati...

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Human Drugs

Vyvgart Hytrulo OKd for Demyelinating Polyneuropathy

FDA approves Halozyme Therapeutics Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for treating chronic inflammatory demyelinating polyneur...

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Federal Register

Workshop in User Fee Meeting Management

Federal Register notice: FDA announces a 7/22 public workshop entitled Best Practices for Meeting Management.