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Regulatory bodies

Government Pulls ‘For Sale’ Signs From US FDA’s White Oak Campus

The General Services Administration’s updated list of “assets identified for accelerated disposition” does not include any buildings at the agency’s headquarters in White Oak, MD after its original list of “non-core” government properties for disposal had more than half the buildings on campus.

Some New Tools, More Old For Supplement Sector Enforcement During Trump’s Second Term

Tariffs on imports from China and look at eliminating self-affirmed GRAS pathway introduced under Trump while DoJ Consumer Protection Branch also continues supplement sector priorities enduring across administrations.

Will Martin Makary Bring Calm To US FDA As Commissioner During Turbulent Times?

Stakeholders are pleading for newly confirmed FDA Commissioner Martin Makary to stand up for the agency's high scientific standards and staff as he begins his term.

Availability Of Counterfeit Supplements Ringing Up Impact On Brand Sales And Consumer Safety

Sales of Bioventra’s probiotic put inventory at “a critical low” as “parallel rise in unverified listings on third-party marketplaces prompted concern among” customers. DoJ and food and drug industry attorney say counterfeiting remains a problem in supplement sector.

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.

Sponsors Of Two Orphans And An Acne Treatment To Defend Marketing Authorization Applications At EMA

Sponsors of three drugs that are in the final stages of the EU regulatory review cycle are due to make the case for marketing approval before the European Medicines Agency.

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.

EU Marketing Approval Gap Between Lilly’s Donamemab and Eisai’s Leqembi Could Narrow

The European Medicines Agency is this week set to issue an opinion on whether pan-EU marketing should be granted to Lilly’s Alzheimer’s disease drug donanemab.

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.