FDA Talking To Industry About Releasing “Complete Response” Letters
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Commissioner Hamburg says conversations are underway with industry to allow the agency to release its reasons for not approving a product, in part so others will not waste funds repeating known failures. FDA is also working to remove user fee revenue from sequestration.
You may also be interested in...
Hamburg Details Some Sequestration Impact On FDA
Commissioner says allowing the sequester would slow implementation of FDASIA provisions and reduce some overseas inspections.
“Emerging Sponsors” Pose Regulatory, Public Relations Challenges For Drug Review Process, FDA’s Jenkins Says
Office of New Drugs director says the agency is seeing more small, inexperienced companies traveling the drug development and approval pathway on their own. However, these firms need more advice from the agency and are all too eager to publicly share their one-sided view about these regulatory interactions.
Sentinel Could Be Used For Pregnancy Safety Studies Under PDUFA VII
User fee program inflation adjustment also proposed to be changed to account for only PDUFA-related personnel.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: