FDA Sets New ANDA Performance Goals for Generics Makers
The FDA has laid out new goals for speeding up its handling of regulatory submissions from generics makers that eventually call for 90 percent of some prior approval supplements to be acted on within six months and ANDA amendments to be acted on within 10 months.
The agency’s new performance goals, which will be phased in over a three-year period, provide incentives for drugmakers to submit high-quality applications by promising faster response times for applications that require fewer amendments, according to two draft guidances.
The new performance goals for both prior approval supplements (PASs) and ANDA amendments apply to applications submitted on or after the start of the next fiscal year, which begins Oct. 1, 2014.
Amendments and their corresponding response times will be categorized into three tiers based on various factors, including whether the amendment is solicited or unsolicited, whether it is major or minor or whether an inspection is necessary to support the amendment.
For example, the FDA says it will seek to act within 10 months on the first major amendment submitted under the Tier 1 standard 60 percent of the time starting next fiscal year. The following fiscal year, that performance goal jumps to 75 percent, and in subsequent years, the goal jumps to 90 percent. Major amendments are those that contain a substantial amount of new data or information not previously submitted to or reviewed by FDA, the guidance said.
The first through third minor amendments will be acted on within three months and the fourth through fifth minor amendments within six months, according to the guidance.
PAS response times, meanwhile, will be predicated on whether an inspection of the manufacturing facility is required. The FDA said it has discretion to determine inspections and that such a decision will depend on the nature of the supplement. “In certain cases, upon submission of the PAS, it will be clear whether the PAS requires an inspection for determining the GDUFA goal date for that PAS,” FDA said.
When an inspection is not required, 60 percent of submissions should receive responses within six months starting next fiscal year, the agency said. The following year that figure rises to 75 percent of submissions, and climbs to 90 percent of submissions in fiscal year 2017, the agency said. The timeframe, however, jumps to 10 months if an inspection is needed. — Bryan Koenig
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.