The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance reinforces its previous commitment to streamlining biosimilar drug ...

The U.S. Food and Drug Administration is moving toward a controversial change in how warning labels appear on dietary supplements, which would reduce how often key disclaimers must be displayed on ...

Just before the change in administration, the Food and Drug Administration (FDA) made headlines by revoking approvals to use the color additive FD&C Red Dye No. 3 in food after January 15, 2027. This ...

NORFOLK, Va. — You used to be able to easily walk into your local pharmacy and get a COVID-19 vaccine, but with new FDA regulations, it might not be as simple in the future. The next round of COVID-19 ...

AICA currently supports auditing against 21 CFR Parts 11, 211, and 600, each mapped at the section and subsection levels.

Please provide your email address to receive an email when new articles are posted on . Speakers at a congressional briefing highlighted safety concerns around counterfeit GLP-1 drugs. A white paper ...

The FDA has faced an extraordinary convergence of political, scientific, legal, and operational pressures over the last year.

Everyone is likely aware that the FDA is one of the agencies tasked with the job of overseeing and ensuring the safety of the nation’s food supply. Have you considered how the cost of the food safety ...

U. S. Food and Drug Administrator Marty Makary called on the agency to close a loophole for companies often used to secure product approval.

Vanda Pharmaceuticals’ seven-year ambition to score a coveted label expansion for sleep drug Hetlioz has taken an unusual turn, with the FDA acquiescing to a formal hearing on the matter. | The ...