FDA Invites Industry Feedback on BLA Submissions, IND Reporting

June 17, 2013
The FDA is seeking industry comment on the litany of requirements for submitting BLAs, to gauge how burdensome the requirements are and if they can be streamlined. In a June 12 Federal Register notice, the FDA asks sponsors to comment on everything from making changes to approved applications and product labels to submitting postmarketing studies.
Washington Drug Letter