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The European Medicine Agency’s revised guideline on the chemistry of active substances — outlining the information companies must provide the agency about the chemical entities used in a drug product — goes into effect this week. Read More
The European Medicines Agency plans to launch an improved version of its adverse event monitoring system, EudraVigilance, in November, with new methods for reporting and analyzing suspected reactions to investigational and authorized products. Read More
Newly minted FDA Commissioner Scott Gottlieb comes into office immediately faced with many challenges: from hiring issues to budget concerns, drug prices and a nationwide opioid addiction crisis. But those who have worked with him say he’s the ideal man for the job. Read More
The FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure, aligning inspection staff into seven product categories — more closely mirroring the organization of the agency’s centers. Read More
A bill to reauthorize FDA user fees for the next five years received voice-vote approval from a House health subcommittee Thursday. The measure now heads to the full Energy and Commerce Committee for consideration. Read More