The Good Old Days: FDA's Jenkins Instructs Reviewers To Meet Original User Fee Review Time Standard
After an almost two-year hiatus from strict adherence to the review timeframes set forth in the Prescription Drugs User Fee Act, Office of New Drugs Director John Jenkins has told the drug review staff that, once again, they should strive to meet the user fee deadlines
You may also be interested in...
Implementer of many drug review changes will leave in January after nearly 32 years of public service.
FDA can't keep pace with requests, placing more pressure on sponsors to ensure submissions are complete.
HELP Committee Chairman Lamar Alexander wants FDA to suggest regs and other bureaucratic requirements that are hindering productivity as part of medical innovation effort.