Lupin Limited has received tentative FDA approval for Enzalutamide Tablets in four strengths, including two additional dosing options beyond the traditionally available Xtandi tablet strengths.
FMI said extending compliance deadlines and improving flexibility will help companies implement food traceability requirements more effectively.
The trade association said that the pace of leadership turnover at the FDA over the past year has created uncertainty among industry stakeholders.
Dr. Marty Makary lasted just over a year as FDA commissioner.
Reports that President Trump approved plans to remove FDA Commissioner Marty Makary have fueled uncertainty around the agency as disputes over vaping, abortion pills and drug approvals intensify.
Makary’s departure would mark the latest shakeup among top federal health officials under the Trump administration.
Comments emphasize the importance of coordinated policy and operational alignment to support affordable and seamless patient access.
Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL, is bioequivalent to the reference listed drug (RLD), Ravicti® Oral Liquid, 1.1 grams per mL, of Horizon Therapeutics U.S. Holding LLC.
Oral GLP-1 therapy achieves double-digit weight loss in trials and launches this month with no food or water restrictions, expanding access through retail and direct-to-consumer channels.
The Council for Responsible Nutrition commended the FDA for clarifying how companies can place the Dietary Supplement Health and Education Act disclaimer on labels.
In a new draft guidance, the FDA proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing.
FDA declined to issue guidance or rulemaking, which CRN said will stifle innovation and perpetuate conflict between supplement makers and pharmaceutical companies.
The US is the largest market for APIs, fueled by high drug use, strong regulation, and top biotech manufacturing.
Decades of use, FDA safety reviews, and leading medical groups confirm the safety of acetaminophen when used as directed.
As the agency opens its books and debate intensifies, the future of U.S. vaccine policy and public confidence may depend on how the next week unfolds.
HDA President and CEO Chester “Chip” Davis, Jr. said the achievement represents progress beyond regulatory compliance.
