PQRI Research May Loosen "Conservative" Product Quality Regs - FDA
Executive Summary
Research stemming from the Product Quality Research Institute may help to loosen FDA's "conservative" product quality guidances and requirements, FDA staff told the American Association of Pharmaceutical Scientists annual meeting Nov. 15 in New Orleans.
You may also be interested in...
PQRI Stratified Sampling Approach To Drug Uniformity Endorsed By Cmte
Stratified sampling and in-process dosage unit testing should be allowed in lieu of blend sampling to demonstrate drug blend uniformity during routine batch production, FDA's Pharmaceutical Science Advisory Committee concluded at its May 8 meeting
PQRI Stratified Sampling Approach To Drug Uniformity Endorsed By Cmte
Stratified sampling and in-process dosage unit testing should be allowed in lieu of blend sampling to demonstrate drug blend uniformity during routine batch production, FDA's Pharmaceutical Science Advisory Committee concluded at its May 8 meeting
FDA Looking At Outside Research Alliances Through Advisory Committees
FDA's Pharmaceutical Science/Nonclinical Studies Advisory Subcommittee is being watched as a model for using advisory committees to expand FDA's collaboration with outside sources.