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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 08, 2019
The guidance answers questions about how the agency awards priority review vouchers to sponsors of treatments for rare pediatric diseases.
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
Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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.
Harmonization of regulatory guidelines not only reduces workloads for manufacturers and regulators but can potentially help to accelerate patient access to vital therapies.
European Union regulators have taken a significant step towards resolving some of the major supply-chain difficulties behind medicine shortages.