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August 16, 2019
FDA sent a warning letter to Emcure Pharmaceuticals, Ltd. because of sterility testing CGMP violations.
August 14, 2019
The agency is planning to clean out its drug listing records and urges companies to update any inaccurate active drug listing submission.
Spectrum Laboratory Products received an FDA warning letter after violations were found at its New Brunswick, NJ facility.
August 12, 2019
Ridge Properties LLC DBA Pain Relief Naturally is voluntarily recalling four lots of 4% lidocaine topical cream and liquid gel products due to microbiological contamination and incorrect potency.
August 08, 2019
The guidance answers questions about how the agency awards priority review vouchers to sponsors of treatments for rare pediatric diseases.
The guidance discusses clinical trial design features that can support approval of treatments of Fabry disease.
August 06, 2019
A US District Court in Washington, DC upheld FDA’s interpretation of clinical need when choosing which substances are approved to use for drug compounding.
The agency is keeping Zolgensma on the market as it evaluates the accuracy of data submitted with the product’s biologics license application.
August 02, 2019
New tools and policies aim to support more complex manufacturing processes.
A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.