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President Trump signed a package of legislation reauthorizing the FDA’s user fee agreements for the next five fiscal years — the culmination of over two years of work and negotiations between the federal government and private industry. Read More
Manufacturers must investigate and report to the FDA any deviation from regulations related to the core requirements of current good tissue practice within 45 days of discovery. Read More
A federal appeals court rejected a challenge by Otsuka Pharmaceuticals to the FDA’s decision to deny exclusive marketing rights to Otsuka’s antipsychotic injectable Abilify Maintena vis-a-vis a competing antipsychotic drug. Read More
The ICH has finalized a Q&A document clarifying its advice on the selection and justification of starting materials used in drug manufacturing. Read More
Shortly after taking office in January, President Trump issued an executive order directing agencies to identify regulations considered to be outdated, unnecessary or ineffective; inhibit job creation; or impose costs exceeding benefits — and now the FDA is asking the public for suggestions. Read More
Drugmakers need to provide adequate details — and include narratives — in describing manufacturing processes in their applications, but can leave out elements such as machinery serial numbers and general GMPs, according to the European Medicines Agency. Read More
A federal judge shut down a Salt Lake City drug compounder Aug. 3 under a consent decree issued in a case brought by the FDA after inspections uncovered numerous regulatory violations. Read More
Drug companies must ensure their products meet federal standards for child-resistant packaging before labeling the packaging as child-resistant, the FDA said in draft guidance issued Aug. 2. Read More
More than 120 questions and answers were added to the European Medicines Agency’s FAQs on the launch of the new EudraVigilance reporting system, set to go live Nov. 22. Read More