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FDA And Generic Drug Quality: Turning Point, Or Precipice?

 
• By Derrick Gingery

OGD Director Geba says generic manufacturers still suffer from extensive quality problems, but GPhA officials argue the industry is doing fine and communications with the agency need to be more uniform.

The generic drug user fee era has only just begun, but so far at least, it has not changed the tenor of the annual Generic Pharmaceutical Association-FDA Fall Technical Conference, which still features tough talk from the agency about generic drug quality problems.

FDA officials, including new Office of Generic Drugs Director Gregory Geba and Acting Office of Compliance Director Ilisa Bernstein, again...

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