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8/18/2000

Group Forms to Speed Drug Approvals

Cheryl A. Thompson

Aiming to speed up the drug-approval process, the Food and Drug Administration Center for Drug Evaluation and Research (CDER) and seven organizations representing industry and academic scientists formed the Product Quality Research Institute (PQRI).

The nonprofit institute, with headquarters at the American Association of Pharmaceutical Scientists (AAPS) in Alexandria, Va., will work to separate unnecessary testing requirements from the types of information needed for high-quality reviews by CDER, AAPS announced last November. Through its working groups, PQRI will recommend "appropriate changes to regulatory policies that will, in most cases, be less burdensome." 

Among the initial areas planned for study are: 

  • Waiver of the requirement for in vivo bioequivalence tests of immediate-release solid oral dosage forms; 
  • Determination of the best methods for detecting, identifying, and measuring the quantity of impurities in drug products; and 
  • Development of in vitro methods to assess the bioavailability and bioequivalence of topical, nasal, and inhalation drug products.

According to PQRI by-laws, CDER does not have to accept any recommendation generated by the institute. 

The research programs, which can be conducted at working-group members' institutions, will be funded by contributions from the pharmaceutical industry. 

In addition to AAPS and CDER, the other founding organizations are the Consumer Healthcare Products Association, the Generic Pharmaceutical Industry Association, the National Association of Pharmaceutical Manufacturers, the National Pharmaceutical Alliance, the Parenteral Drug Association, and the Pharmaceutical Research and Manufacturers of America. AAPS manages the institute's day-to-day activities.