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Pharmaceutical Quality And Generic Drugs: Janet Woodcock Explains Her Vision

 
• By Derrick Gingery

The Office of Generic Drugs may evolve to focus more on clinical issues as the new Office of Pharmaceutical Quality creates uniform standards for manufacturing process engineering and other production areas, the CDER director says in an interview.

The proposed Office of Pharmaceutical Quality appears just as important to the evolution of the Office of Generic Drugs as it is to FDA’s focus on the importance of product manufacturing standards.

While still many months away from enactment, OPQ is envisioned to let FDA set a consistent quality

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