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 is working rapidly to establish a mutual inspection program with the EU that uses similar GMPs and quality metrics, CDER Director Janet Woodcock said Monday, adding that the current system of different expectations is not sustainable. Read More
A U.S. Supreme Court ruling last week that patents should be presumed valid could make it easier for drugmakers to sue for patent infringement, a patent law attorney said. Read More
Drugmakers seeking marketing authorization in the EU may request a meeting with the European Medicines Agency to discuss questions posed by the agency’s advisory committees, updated guidance says.
Read More
A House subcommittee chairman wants the FDA to explain its practices relating to publication and distribution of untitled letters, after hearing complaints from companies that the agency’s policies are inconsistent and, in some cases, unfair. Read More
The FDA is clarifying its definition of “established conditions” to ensure drugmakers properly report postapproval chemistry, manufacturing and control changes in NDAs, ANDAs and BLAs. Read More