Legislation

“Dietary Supplement Regulatory Uniformity Act” would prohibit states from adding requirements and rules for supplement manufacturing and sales on top of FDA regulations.

Hawaii proposes age-restricted sales but, unlike similar bills also filed in Alaska, Massachusetts, Michigan and Washington legislatures, would require behind-the-counter storage to limit consumer access in stores.

Changing self-GRAS regulation, providing NDIN safety and identity guidance and modernizing supplement industry regulatory framework are on FDA’s “2026 priority deliverables,” but not requirement for public listing of all supplements available.

Industry trade group executives discuss two central questions: What trends, challenges, or opportunities do you expect will define the industry in 2026? Did developments you anticipated materialize?

New compliance measures for big pharma under the amended EU sustainability reporting and due diligence directives could lead to new contractual requirements for smaller partners.

Marking the latest step in the long-running saga of Hikma and Amarin’s induced infringement dispute over Vascepa (icosapent ethyl), the US Supreme Court has agreed to review the litigation, which cuts to the heart of key issues around skinny-label generics and carved-out indications.

CRN’s support, a pivot from qualified backing for the previous bill, came after the senator added language to relieve firms of some responsibility around providing all claims for their products to FDA to include public-facing list.

“Our sense is that companies are currently focused on timing, scope and execution. For example, knowing when a final order might issue … We also imagine that formulators are scrutinizing the proposed list of permitted combinations, the 6% cap, and the permitted dosage forms,” say ArentFox Schiff att

In PDUFA reauthorization subgroup meetings, CHPA suggests expanding FDA’s special protocol assessment program to include OTC drug studies before FDA notes Congress has required it to provide switch-specific guidance before current PDUFA expires.

Agency says FY 2026 Tier 1 OMOR fees are $587,529 and Tier 2 fees are $117,505. The fees, due to FDA when an OMOR is filed, aren’t included in OMUFA target revenue calculation for each fiscal year based entirely on annual facility registration fees.

The version of the Critical Medicines Act adopted by a key committee of the European Parliament could mean uncertainty for the manufacturers of orphan drugs, warns industry.

Sunscreen products industry and public health advocacy groups have been critical that FDA has not approved a new filter since 1999 even as countries in Europe and other regions allow using numerous additional ingredients in sunscreens.