Regulatory bodies

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.

But the Senate’s reduction would not be as much as the House of Representatives and President Trump proposed earlier this year, which is likely a win for the agency.

Regulatory reliance processes for drug registration and clinical trial application approvals in Brazil have not met their “full potential,” says Brazil’s medicines regulator.

Miller, FDA acting deputy associate commissioner for inspections and investigations, said veteran inspectors will retain their specialties and potentially acquire new expertise, while new recruits will begin as generalists and then be encouraged to pick a focus area.

State and territory attorneys general urge congressional leaders to clarify definition of hemp, which they say “bad actors have exploited due to a perceived loophole” of 0.3% delta-9 THC level stated in 2018 farm bill de-scheduling as controlled substances some ingredients extracted from cannabis.