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in January, President Trump issued an executive order directing agencies to identify regulations considered to be outdated, unnecessary or ineffective; inhibit job creation; or impose costs…
Sens. Elizabeth Warren (D-Mass.) and Shelley Moore Capito (R-W.Va.) urged FDA Commissioner Scott Gottlieb to task the agency’s opioid policy steering committee with promoting “partial fill” policies to limit the…
The FDA cited two compounders and two drugmakers for failure to maintain aseptic conditions and for other shortcomings, as reflected in Form 483 inspection reports. Source: Drug GMP Report
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…
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meet federal standards for child-resistant packaging before labeling the packaging as child-resistant, the FDA said in draft guidance issued Aug. 2. Source: Drug GMP…
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. Source:…
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