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Regulation

US FDA Reorganization Set Stage To Improve Food Programs, But Slim Budget Grabs Spotlight

“It's kind of a free for all,” says longtime FDA funding advocate Steven Grossman. FDA knew funding it requested “was totally inadequate to the needs. So, Food Chemical Safety is stuck there with about six or eight other purposes the money could have been used for.

Combating Bioequivalence Data Fraud: Indian CROs Face Mandatory Registration

As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.

US FDA Under Makary: MAHA With A Lighter Touch

US FDA Commissioner nominee Martin Makary is being embraced by industry, and Senate Democrats, as a more traditional pick than other Trump Administration nominees, but the Make America Healthy Again agenda still is clearly coming to the agency.

Traceability Rule Compliance Extended For Providers Of Herbals, Other Food Ingredients

FDA says “extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements—ultimately providing FDA and consumers with greater transparency and food safety.”

PharmaMar’s Aplidin Back On EMA’s Agenda After Conflict Of Interest Controversy

The European Medicines Agency is re-evaluating the marketing application for Aplidin. The initial application was rejected in 2018, but that rejection was revoked last year following a court case for another company’s drug that clarified impartiality requirements for experts consulted by the EMA.

BGMA Hits Back At ABPI Complaints Over UK Pricing Scheme

Complaints from UK originator association the ABPI over rising payments required by the country’s voluntary scheme for branded medicines pricing have been denounced by the BGMA, which says the differentiated scheme is “delivering precisely as it was intended.”

Longer ACNU Rule Review Gets Kennedy Signature

Notice published on 21 March is a word-for-word copy, other than different dates, of a document published on 24 January, Kennedy says the ACNU final rule’s effective date is delayed until 27 May, two months later than the initial delayed effective date.

No Longer Voluntary, MoCRA Drives Drastic Increase In Registered Companies, Products

Preliminary registration data released by FDA offers a first glimpse of the Modernization of Cosmetics Regulation Act’s impact on information the agency has at hand.

New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Vimkunya, Bavarian Nordic's chikungunya vaccine.

US Monograph Facility Fees Due In Six Weeks While DOGE Subjects FDA To Rapid Changes

FDA’s OMUFA facility fees for FY2025, due on 2 June, increase nearly $2,400 to $37,556 for OTC monograph drug manufacturers and $2,200 to $25,037 for contract manufacturers. Overall target OMUFA fee total is just short of $36.47m, up from $32.25m for FY2024.