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Rhinosinusitis Drug Development Guidance

[ Price : $8.95]

FDA publishes a guidance to help in the development of drug and biological products to treat chronic rhinosinusitis with nasal pol...

Compounding Inspection, Oversight FAQs

[ Price : $8.95]

The FDA Compounding Quality Center of Excellence posts 14 questions and answers about compounding inspections and oversight.

FDA OKs 1st Diabetes Cellular Therapy

[ Price : $8.95]

FDA approves CellTrans Lantidra, the first cellular therapy to treat some patients with Type 1 diabetes.

Info Collection on Advisory Committee Regs

[ Price : $8.95]

Federal Register notice: FDA sends an information collection revision to OMB entitled FDA Advisory Committee Regulations."

Info Collection on Device Conformity Assessments

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection revision entitled Accreditation Scheme for Conformity Assessme...

18-Page FDA-483 on Ipca Laboratories Inspection

[ Price : $8.95]

FDA releases the form FDA-483 with 11 observations from an inspection at Indias Ipca Laboratories Ratlam API facility.

BioMarin Gene Therapy for Hemophilia A OKd

[ Price : $8.95]

FDA approves a BioMarin Pharmaceutical BLA for Roctavian (valoctocogene roxaparvovec-rvox) gene therapy for treating adults with s...

Alvotech Complete Response Due to Inspection

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FDA sends Alvotech a complete response letter for its BLA for AVT02, a high-concentration biosimilar candidate referencing AbbVies...

2 Roche Assays Cleared for Alzheimers

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FDA clears two Roche assays that measure two biomarkers of Alzheimer's pathology beta-amyloid and tau proteins in adults over 55...

Prioritize Cancer Trial Diversity: Researchers

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FDAs Oncology Center of Excellence and other researchers stress the need to prospectively improve the diversity of cancer trial pa...