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Food and Drug Administration (FDA) Regulatory Requirements Expedited Actions Process

BakerHostetler

FDA’s ‘PreCheck’ Program: New Pathway to Acceleration of US Drug Manufacturing

BakerHostetler on

The U.S. Food and Drug Administration (FDA) has announced FDA “PreCheck,” a new regulatory program intended to streamline the development and approval of domestic pharmaceutical manufacturing facilities. ...more

Venable LLP

Life in the Fast Lane! FDA Announces the Commissioner's National Priority Voucher Program

Venable LLP on

On June 17, the Food and Drug Administration announced the establishment of the Commissioner's National Priority Voucher (CNPV) program. Although initial details are sparse, the CNPV promises fast action, allowing drug...more

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