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FDA Reassures Patients Of Generic Drug Quality Amid Questions In Media Analysis

 
• By Derrick Gingery

Commissioner Scott Gottlieb and CDER Director Janet Woodcock say in joint statement that patients can be confident generics are safe and effective and recent media reports misinterpreted inspection and other data when suggesting the contrary.

Anti-recessionary injection (vaccination) by hundred dollar denomination close up on a black background

The US FDA took the unusual step of publicly rebutting a series of media reports raising questions about its oversight of generic drug manufacturers, hoping to restore any wavering confidence in its facility inspection and pharmacovigilance work.

Commissioner Scott Gottlieb and Center for Drug Evaluation and Research Director Janet Woodcock issued a 2,685-word statement Feb. 22 explaining its pharmacovigilance systems and reminding the public and stakeholders...

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