US FDA Gets A New Lawyer: Rebecca Wood Named Chief Counsel
Former Sidley Austin partner brings a wealth of experience in drug product liability litigation and federal preemption. She replaces agency veteran Elizabeth Dickinson, who will stay on as senior deputy to the chief counsel.
You may also be interested in...
Generic Labeling Rule: Will Delay Spell Doom?
FDA aims to finalize proposed reg that would allow ANDA holders to unilaterally make safety labeling changes by July 2016, but opposition continues to swirl.
Label Change Proposal From GPhA, PhRMA Makes FDA Responsible For Timing
“Expedited Agency Review” idea would require an FDA review of proposed safety-related labeling changes before they are made and end the CBE-0 system brand companies already use and generics could be required to adopt.
FDA Generic Labeling Rule: PhRMA, GPhA Offer Degrees Of Dislike
GPhA argues it would be impossible for ANDA applicants to unilaterally change their labels; Pfizer suggests FDA only allow one request for a proposed labeling change on a given safety issue at a time.