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Inspections Focusing on Management Responsibility: FDA

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FDA Office of Regulatory Affairs Division of Pharmaceutical Quality Operations III program director Jeffrey Meng tells an industry...

Pfizer/BioNTech on Encouraging Covid Booster Data

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Pfizer and BioNTech announce results showing that their current authorized bivalent booster vaccine provides a greater increase in...

Iovance Pushes Back BLA for Melanoma Therapy

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Iovance Biotherapeutics delays its completion of a rolling BLA submission for lifileucel, an investigational tumor infiltrating ly...

Animal Drug User Fees Reauthorization Meeting

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Federal Register notice: FDA announces a 12/7 public meeting entitled Animal Drug User Fee Act to discuss reauthorizing the user f...

Bernie Sanders to Head HELP Committee

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Senator Bernie Sanders (I-VT) looks to become chairman of the Health, Education, Labor and Pensions (HELP) Committee after current...

Guidance on Compounding Amoxicillin Due to Shortages

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FDA issues an immediately in effect guidance on the preparation of beta-lactam oral antibiotic suspension products compounded by p...

FDA Withdraws 10 No-Longer-Marketed ANDAs

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Federal Register notice: FDA withdraws approval of 10 ANDAs from multiple applicants after they told the agency the products were ...

Comments Sought on Proposed NDC Revision

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CDER lead consumer safety officer Leyla Rahjou-Esfandiary says the agency wants to receive comments by 11/22 on its proposal to in...

FDA Warns 7 Supplement Companies About CV Claims

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FDA warns seven dietary supplement manufacturers they are illegally selling products that claim to treat cardiovascular disease.

FDA Approves Lilly Interchangeable Insulin Product

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FDA approves Lillys Rezvoglar as the second interchangeable biosimilar insulin product.