CHPA calls for FDA stability after Makary departure
The trade association said that the pace of leadership turnover at the FDA over the past year has created uncertainty among industry stakeholders.
FDA
Makary exits FDA after turbulent tenure
Dr. Marty Makary lasted just over a year as FDA commissioner.
Marty Makary’s future at the FDA hangs in the balance
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.
WSJ: Trump to fire FDA chief
Makary’s departure would mark the latest shakeup among top federal health officials under the Trump administration.
NACDS submits comments to FDA on expanding access to nonprescription drugs
Comments emphasize the importance of coordinated policy and operational alignment to support affordable and seamless patient access.
Lupin gets U.S. FDA approval for Glycerol Phenylbutyrate Oral Liquid
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.
FDA approves Lilly’s Foundayo, first unrestricted GLP-1 pill
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.
CRN praises FDA for clarifying DSHEA disclaimers’ placement
The Council for Responsible Nutrition commended the FDA for clarifying how companies can place the Dietary Supplement Health and Education Act disclaimer on labels.
FDA aims to speed up biosimilar development and lower drug costs
In a new draft guidance, the FDA proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing.
CRN criticizes FDA over drug preclusion ruling
FDA declined to issue guidance or rulemaking, which CRN said will stifle innovation and perpetuate conflict between supplement makers and pharmaceutical companies.
API industry growth accelerates as US drives demand
The US is the largest market for APIs, fueled by high drug use, strong regulation, and top biotech manufacturing.
CHPA disputes autism claims and defends acetaminophen safety
Decades of use, FDA safety reviews, and leading medical groups confirm the safety of acetaminophen when used as directed.
FDA reviews COVID vaccine safety under political pressure
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 marks DSCSA implementation milestone for distributors
HDA President and CEO Chester “Chip” Davis, Jr. said the achievement represents progress beyond regulatory compliance.
FDA Center heads to take the stage together at CHPA Regulatory Conference
Each year, CHPA’s RSQ Conference unites industry, regulators, and academia to focus on the evolving self-care sector.
FDA wants opioid manufacturers to update prescribing information regarding long-term use
These changes follow a public advisory committee meeting in May that reviewed data showing serious risks—such as misuse, addiction, and both fatal and non-fatal overdoses—for patients who use opioids over long periods.