FDA, drug industry and scholars find success in effort to tackle regulat...( y provide representative results. The ...)

FDA, drug industry and scholars find success in effort to tackle regulatory issues

y provide representative results. The FDA has agreed to release a revised draft guidance document on blend uniformity after receiving PQRIs recommendation.

PQRI will collaborate with the International Pharmaceutical Aerosol Consortium (IPAC) to address several issues associated with the chemistry, manufacturing and control requirements for oral and nasal inhalation products defined in draft FDA guidance. The specific issues to be studied are currently being identified.

PQRI is also considering an FDA request for help in addressing several issues associated with drug counterfeiting.

"FDA is extremely supportive of PQRI," said Helen Winkle, Acting Director, Office of Pharmaceutical Sciences, FDA. "FDA sees PQRI as an excellent means for leveraging intellectual and laboratory resources and promoting regulatory research programs to enhance our science base."

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Contact: Debbie Werfel
werfeld@aaps.org
703-248-4743
American Association of Pharmaceutical Scientists
11-Dec-2000

Page: 1 2
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