FDA/industry user fee II proposal would cut review deadline to 10 months from current 12.
This article was originally published in The Tan Sheet
Executive Summary
FDA/INDUSTRY USER FEE II PROPOSAL WOULD CUT NDA REVIEW DEADLINE BY TWO MONTHS, from 12 to 10 months, for standard NDAs and biological licensing applications. Under a user fee reauthorization proposal agreed upon by FDA, the Pharmaceutical Research & Manufacturers of America and the Biotechnology Industry Organization, FDA would cut the review time for manufacturing supplements from six to four months.
You may also be interested in...
Topical Antimicrobial Proposed Rule Slated For March in “Unified Agenda”
A proposed rule on consumer topical antimicrobial products is scheduled for March 2006 release, according to HHS' semi-annual "unified agenda" published in the Federal Register Oct. 31
Topical Antimicrobial Proposed Rule Slated For March in “Unified Agenda”
A proposed rule on consumer topical antimicrobial products is scheduled for March 2006 release, according to HHS' semi-annual "unified agenda" published in the Federal Register Oct. 31
Topical Antimicrobial Proposed Rule Slated For March in “Unified Agenda”
A proposed rule on consumer topical antimicrobial products is scheduled for March 2006 release, according to HHS' semi-annual "unified agenda" published in the Federal Register Oct. 31