Guide highlights key compliance scenarios—from FDA actions to global expansion—where consulting is essential. IRVINE, ...
Senior Food and Drug Administration leaders are planning for cutbacks to the number of routine food and drug inspections conducted by the agency, multiple officials say, due to steep layoffs this week ...
The Food and Drug Administration is developing a plan to shift more food safety inspection responsibility to state agencies over the course of five years, according to two sources familiar with ...
After years of discussion, the Food and Drug Administration may shift responsibility for routine food safety inspection to the states. While industry and food safety experts say it's a logical move, ...
Scholar Rock (NASDAQ:SRRK) said it has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug ...
In June 2025, the FDA finalized its Remote Regulatory Assessment framework, making remote records requests a permanent ...
WASHINGTON (AP) — When Health Secretary Robert F. Kennedy Jr. announced sweeping job cuts at his department last month, he said that safety inspectors who oversee U.S. foods and drugs wouldn't be ...
The US Food and Drug Administration (FDA) has cited a medical device manufacturer and a contract drug testing laboratory for ...