Regulatory bodies

FDA looks to Congress for authority to require registration for all supplements available for sale in US for public-facing product listing but no authority can produce list of dietary ingredients available pre-DSHEA.

The European Medicines Agency scheduled oral explanation meetings for Sanofi’s MS drug and two other products nearing the end of their EU regulatory review cycle. These meetings typically give companies a final chance to convince the agency their drugs merit approval.

With Richard Pazdur’s abrupt exit marking the fifth CDER leadership change in a year, the AAM is urging continuity and stability amid the ongoing turbulence.

Enforcements at facilities in Missouri operated by Shaman Botanicals and Relax Relief Rejuvenate Trading were preceded by administrative detention orders, FDA’s first use of the authority since its reorganization in October 2024.

In another surprise leadership move, Commissioner Martin Makary named Høeg, who has stirred controversy with her involvement in FDA vaccine issues, the interim replacement for Richard Pazdur.

Pazdur’s departure just weeks into the job creates more uncertainty for the biopharma industry and an embarrassing situation for Commissioner Martin Makary, who personally lobbied him to take the position.

International reliance mechanisms for approving drugs have an important place, but the UK regulator should increase focus on becoming a first approver of medicines, according to the British pharmaceutical industry.

After AI’s magic wand status, it's now come to Google and Open AI CEOs talking of the likelihood of a bubble burst. In this interview, Parexel’s India head discusses how to view returns on such investments, the CRO’s own use cases and the US FDA’s keenness on transparency and open dialogue.

Agency intends to use information from comments to guide its planning for a public meeting during 2026, according to a Federal Register notice. A GAO report is due in a year to Congress profiling FDA’s progress on making more drugs available nonprescription through OTC switch applications.

FDA leadership drama continues after Richard Pazdur was elevated to drug center director. Can Pazdur, CBER Director Vinay Prasad and Commissioner Martin Makary get along?

Treasurer Jim Chalmers has blocked the AU$677m bid following FIRB advice that the acquisition posed unacceptable risks to Australia’s critical medicine supply chains.

Regardless of THC level and even though the US hemp product marketplace is growing, FDA regulations prohibit the botanical’s use as a dietary ingredient or food additive because it’s been studied or approved for use as a drug in the US.