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Food and Drug Administration (FDA) › Supply Chain › 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

Sheppard Mullin Richter & Hampton LLP

FDA Grants COVID-19 Diagnostic Emergency Use Authorizations, And Other Recent FDA Actions to Address COVID-19

Sheppard Mullin Richter & Hampton LLP on

The U.S. Food and Drug Administration (FDA) issued two Emergency Use Authorizations (EUA) for commercially distributed COVID-19 diagnostic tests at the end of last week. The first authorization was issued to Roche Molecular...more

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