Mandatory Trial Reporting To Be Required For Nearly Half Of IND Protocols
Almost half of investigational new drug trial protocols submitted to FDA will be subject to mandatory reporting requirements for trials of drugs for serious or life-threatening diseases, the agency estimated in a March 29 notice of draft guidance availability
You may also be interested in...
FDA is planning a consensus conference to discuss issues surrounding single-patient INDs and expanded access programs for unapproved oncology agents, Oncologic Drug Products Division Medical Team Leader Grant Williams, MD, told FDA's Oncologic Drugs Advisory Committee June 7.
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011