FDA PreCheck pilot program selects Eli Lilly, Regeneron

The FDA estimates the PreCheck program could save participating companies up to 14 months by reviewing facilities while they ...

Eli Lilly, Regeneron among first companies selected for FDA initiative to speed review of new manufacturing facilities

Eli Lilly and Regeneron are among the first seven companies the FDA has selected for its PreCheck Pilot Program, CNBC has ...
Fierce Pharma

FDA selects Lilly, Regeneron, Fujifilm, 4 others for PreCheck Pilot Program

Biopharma giants Eli Lilly and Regeneron and rapidly growing contract manufacturers Fujifilm and Cellares, are among the ...
TMCnet

FDA Selects Kyowa Kirin for PreCheck Pilot Program to Accelerate Manufacturing Timelines and Enhance Supply Chain Resilience

Strategic collaboration at Sanford, North Carolina facility, currently under construction, to optimize cGMP validation, accelerate time-to-market for complex biologics, and shore up U.S. medicine ...
Truckinginfo

FDA Program Will Put More RFID Tags in the Freight Stream

The Food and Drug Administration Monday announced an initiative to encourage the use of RFID by drug companies. Mark your calendar: June 30, 2026 (10:00 a.m. PDT). A 37.5% ownership interest in ...
RAPS

Study: FDA’s expedited programs play increasing role in bringing novel drugs to market

Expedited development and review programs established by the US Food and Drug Administration (FDA) have a growing role in bringing drugs and biologics to market, with novel orphan and nonorphan ...
FiercePharma

FDA rolls out 1-day assessment pilot in bid to refocus inspection resources

In a bid to better deploy its boots-on-the-ground resources, the FDA is pulling back the curtain on a new pilot program, under which the regulator is leveraging “one-day inspectional assessments” to ...
Medical Xpress

FDA unveils drugs to receive expedited review in support of 'national priorities'

The Food and Drug Administration on Thursday announced the first round of experimental drugs that will receive drastically expedited reviews at the agency, part of an effort to prioritize medicines ...
TMCnet

Kriya Selected for FDA PreCheck Pilot Program

Kriya Therapeutics, Inc. ("Kriya"), a biotechnology company developing durable medicines for chronic diseases, today announced it has been selected by the U.S. Food and Drug Administration (FDA) to ...