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.
The FDA appears to have anticipated one issue drugmakers raised at a Monday public meeting on its quality metrics draft guidance — extending the comment period on the document until Nov. 27. Read More
The agency wants to improve nomenclature following complaints by generic drug and excipient makers that the current format delays ANDA filings. Read More
Industry questioned whether the FDA has the legal authority to enforce its quality metrics guidance during a Monday public meeting on the draft document. Read More
The proposal includes accelerated approvals of drugs, specified timelines for deciding applications and increased public access to information. Read More
The European Medicines Agency is seeking feedback on the International Conference on Harmonization’s revised E6 guideline, which adds new recommendations for sponsors on developing risk-based quality management systems for clinical trials. Read More
With more than 80 percent of APIs coming into the U.S. from foreign sites, the FDA is stepping up its enforcement activities to better manage global supply chains. At the same time, India and China are also expanding their inspection teams. Read More