We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Drug sponsors hoping to submit an alternative postmarket report, known as the periodic benefit-risk evaluation report (PBRER), at a different frequency than required should plan to file a waiver request, the FDA said. Read More
The European Directorate for the Quality of Medicines and a number of foreign pharmaceutical authorities have agreed to improve information-sharing efforts and to strengthen collaboration. Read More
The European Medicines Agency adopted a final guideline setting out the information required for the evaluation of active chemical substances used in drug products. Read More
With just three work weeks left in its lame duck session, many are expecting the Senate to vote on its 21st Century Cures legislation package. Read More
As a precursor to the FDA’s official implementation of a quality metrics reporting program, the agency will begin accepting voluntary data submissions from drugmakers on the quality of their finished dosage form drugs and APIs in early 2018 for a pilot run of the risk-based system. Read More
Three years after issuing proposed guidance that laid out the FDA’s expectations for quality agreements with contract manufacturers, the agency has firmed up and expanded what drug companies must do to ensure that their agreements with CMOS are clear and enforceable. Read More
The FDA has updated final guidance on safety testing for drug metabolites to conform to the ICH’s latest standards on toxicity detection and testing. Read More