WYETH-AYERST FOLLOW-UP OF DRUG QUALITY PROBLEMS CRITICIZED BY FDA
WYETH-AYERST FOLLOW-UP OF DRUG QUALITY PROBLEMS CRITICIZED BY FDA in a July 8 warning letter. The company's follow-up investigations into quality problems with antibiotic products and subsequent conclusions are "grossly inadequate and scientifically unsound," a warning letter from FDA's Philadelphia District Office declares. The warning letter resulted from an April 24 through June 14, 1994 routine inspection of Wyeth-Ayerst's West Chester, Penn. manufacturing facility.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth