A new regulation taking effect on July 1 will require California’s bars, nightclubs and similar licensed establishments to ...

Endoscopy devices restricted from import accounted for about 1% of the company’s consolidated revenue in its latest fiscal ...

General Food Labeling Requirements and Labeling-Related Sample Analysis — Domestic and Import” replaces the previous 2010 ...

FDA Commissioner Martin Makary, MD, shared his vision for a “New FDA” with biopharma leaders attending BIO in Boston.

ProPublica paid Redica for access to FDA inspection records and ultimately reviewed reports spanning more than two decades. To gauge what the FDA knew about the drugs before and after they were ...

However, a follow-up inspection in February 2024 uncovered additional concerns related to quality control and record-keeping. It is unclear whether these issues overlap with previous findings. “While ...

At the conclusion of the inspection, the US FDA issued a Form-483, with 8 observations,” Sun Pharma said in a regulatory filing. ALSO READ GST on sin goods, cars may go up ...

Syngene International said that the United States Food and Drug Administration (US FDA) conducted a good clinical practices (GCP) compliance inspection of the company's facility located at Semicon ...

NATCO Pharma said that the U.S. Food and Drug Administration (FDA) had conducted an inspection at the API manufacturing plant located in Mekaguda, Hyderabad, India, which was conducted from 09 to 13 ...

Capricor Therapeutics (CAPR) announced the completion of the Food and Drug Administration’s pre-license inspection of its San Diego manufacturing facility for Deramiocel, the company’s lead ...