FDA Related News

Antimicrobial Drug and Susceptibility Test Guidance

FDA issues a final guidance on coordination of development and review of antimicrobial drugs with antimicrobial susceptibility tests.

Human Drugs

Quantitative Framework Could Aid Drug Review: Researchers

Management researchers suggest a more flexible approach to FDA drug review and evaluation.

Medical Devices

Edwards, Boston Settle all Patent Disputes for $180 Million

Edwards Lifesciences says it is making a one-time payment of $180 million to Boston Scientific as part of a settlement of all outstanding patent dispu...

Biologics

FDA Approves Expanded Adacel Use

FDA approves an expanded indication for Sanofis Adocel as a repeat vaccination delivered eight or more years after the initial vaccination to help pro...

Human Drugs

Eisai/Purdue NDA Filed for Insomnia

Eisai and Purdue Pharma submit an NDA for lemborexant for treating insomnia.

Human Drugs

Draft ANDA Amendment Submission Guidance

FDA issues a draft guidance on amendments and requests for final approval to tentatively approved ANDAs.

Human Drugs

FDA Approves Tevas Generic Seizure Drug

FDA approves a Teva Pharmaceuticals ANDA for the first generic version of Lundbecks Sabril (vigabatrin) 500 mg tablets for treating complex partial se...

Human Drugs

Rare Diseases Drug Development Draft Guidance

FDA issues a revised draft guidance on common issues in drug development for rare diseases.

Medical Devices

FDA Clears Immuno Concepts LKS Tissue Slides

FDA clears an Immuno Concepts 510(k) for the Histofluor Rodent LKS Tissue Slides for manual and Image Navigator use.

Human Drugs

FDA Final Data Integrity Guidance Reviewed

Duane Morris attorneys review key provisions in the FDA final guidance on data integrity and CGMP compliance.