FDA Aims To Bolster Generics' Image With Research, Regulatory Changes
FDA's Office of Generic Drugs is planning a multi-prong approach to boost public confidence in generic drugs, including scientific publications and possible changes in approval guidance, following a series of high-profile concerns raised about the quality of the products
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The public’s acceptance of generic drugs is at an all-time high. But manufacturing issues, shortages of life-saving medications and questions about the overall quality of generics are testing the system like never before. FDA’s tough love message to industry: fix the manufacturing problems—or risk your reputation.
One project will look at tablet size, odor and other characteristics that in the past have been a source of public complaints about generics.
It didn't seem like deliberate choice to play good cop-bad cop, but Acting Office of Generic Drugs Director Keith Webber and Center for Drug Evaluation and Research Director Janet Woodcock offered a near textbook version of it at the recent Generic Pharmaceutical Association Fall Technical Conference.