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Pharmaceutical Industry 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

Goodwin

Move Fast: FDA is Accepting Submissions for the Pilot Program Class for FDA Commissioner’s National Priority Voucher Program

Goodwin on

FDA is now accepting submissions to the Commissioner’s National Priority Voucher (CNPV) pilot program, and with only five vouchers to be awarded as part of the initial year of the program, the competition is anticipated to be...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

Woods Rogers

Expedited Trademark Registration For COVID-19 Products and Services

Woods Rogers on

In response to the COVID-19 outbreak, and the need to quickly develop medical products and services to fight the virus, the United States Patent and Trademark Office (“USPTO”) is allowing the trademark examination process for...more

Fox Rothschild LLP

Expedited TM Review For Covid-19 Products/Services

Fox Rothschild LLP on

Last month, the United States Patent and Trademark Office’s (USPTO) began an initiative to expedite the review of, and waive the fees related to, trademark applications for marks used to identify qualifying Covid-19 products...more

Sheppard Mullin Richter & Hampton LLP

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

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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