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December 20, 2017
Implementation of the Packaging Serialization Standard cuts serialization costs, shortens deployment time, and expedites compliance with anticounterfeiting regulations.
FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.
December 18, 2017
The draft guidance provides guidance on the development of drugs and biologics in which a nanomaterial is present in the finished dosage form.
The agency published guidance on the research and development of individualized therapies.
December 14, 2017
The draft guidance gives recommendations on how certain oral drug products should be labeled regarding gluten.
December 12, 2017
The authors hope to facilitate further collaboration among all the stakeholders for USP OTC Monograph Modernization with the goal of identifying a satisfactory approach for USP, FDA, and industry.
December 07, 2017
An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.
December 02, 2017
The European Commission’s effort to relax supplementary protection certificates to help generic-drug makers and biosimilars producers has sparked strong opposition from the research-based pharmaceutical sector.
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
November 27, 2017
The new guidelines discuss GMPs and patient protection specific to advanced therapy medicinal products.