House Accutane Safety Hearing Will Include Testimony From FDA's Woodcock
Executive Summary
FDA Center for Drug Evaluation & Research Director Janet Woodcock, MD, is scheduled to testify on patient safety issues related to Roche's acne drug Accutane during a Dec. 5 hearing convened by the House Government Reform Committee.
You may also be interested in...
Accutane Update Is First Time For Wholesaler Instructions In A Product Label
A recently approved risk management program to prevent pregnancies in patients taking isotretinoin (Roche's Accutane and generics) includes the unprecedented addition of wholesaler-focused instructions to prescription drug labeling
Accutane Update Is First Time For Wholesaler Instructions In A Product Label
A recently approved risk management program to prevent pregnancies in patients taking isotretinoin (Roche's Accutane and generics) includes the unprecedented addition of wholesaler-focused instructions to prescription drug labeling
FDA Plans To Require Submission Of Overseas Label Changes Under Draft Rule
FDA is developing a proposed rule that would require pharmaceutical manufacturers to notify the agency of labeling changes that occur overseas, FDA Office of Drug Evaluation V Deputy Director Jonca Bull, MD, indicated during a Dec. 5 House Government Reform Committee hearing.