‘First Generic’ Definition Is Two-Sentence Tug Of War For FDA, Industry
FDA offers two-prong criteria to determine which ANDAs would get priority in review system; industry wants expanded classification that includes drug shortages.
You may also be interested in...
Office of Generic Drugs wants to allow project managers to inform sponsors of major deficiencies before ‘complete response’ letter as part of ‘go/no go’ effort.
FDA officials still looking for input after transparency issue not widely addressed during GDUFA policy meeting.
CDER staff manual outlines seven categories of submissions that can qualify for expedited review, including some ANDAs with patent certifications and supplements that have the potential to create an “extraordinary hardship” for a sponsor if not addressed quickly.