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.
Biologics makers developing drugs based on bacteria and viruses should conduct preclinical and clinical studies to determine if infection could be unintentionally transmitted from treated patients to other individuals, the FDA says. Read More
The FDA submitted Designation of Official Names and Proper Names for Certain Biological Products as a proposed rule to the Office of Management and Budget on Friday, but would not comment on whether it is the expected guidance on naming biosimilars. Read More
A drug pricing watchdog was rebuffed Monday in its attempt to get the U.S. Patent and Trademark Office to review two patents on Acorda Therapeutics’ blockbuster multiple sclerosis drug Ampyra — the first of 18 petitions the Coalition for Affordable Drugs has filed with the agency since February. Read More
The FDA appears to have anticipated one issue drugmakers raised at a Monday public meeting on its quality metrics draft guidance — extending the comment period on the document until Nov. 27.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