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FDA, U of MD Workshop on Pediatric Trial Designs

[ Price : $8.95]

FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation host a two-day workshop entitled Adva...

NDA Filed for Urea Cycle Disorders Drug

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Acer Therapeutics and Relief Therapeutics submit an NDA for ACER-001 (sodium phenylbutyrate) for treating urea cycle disorders.

Intended Use Rule Clarifies Off-label Promotion Implications

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Attorneys from Dechert pick apart FDAs recent intended use rule, which clarifies that the agency will not make a determination of ...

Guide on Prostate Cancer Clinical Endpoints

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FDA issues a final guidance entitled Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Surviv...

Qiagen EUA for Rapid Covid Antigen Test

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FDA grants Qiagen an emergency use authorization for its QIAreach SARS CoV-2 antigen test, a rapid portable test that can process ...

Genzyme BLA Approved for Pompe Disease

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FDA has approved a Genzyme BLA for Nexviazyme for intravenous infusion to treat patients one year of age and older with late-onset...

Class 1 Recall on Boston Scientific Pacemakers

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FDA classifies as Class 1 a Boston Scientific recall of its Ingenio pacemakers and CRT-Ps due to safety mode transition error.

Guide on Near Infrared Analytical Procedures

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FDA releases a final guidance on Development and Submission of Near Infrared Analytical Procedures.

FDA Implementing Fallout from Drug/Device Case

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Federal Register notice: FDA announces its implementation of a court decision that ruled the agency is not afforded discretion whe...

MOU Period Extended for Compounded Drugs

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Federal Register notice: FDA extends the period for states to decide whether to sign the final standard memorandum of understandin...