Regulatory bodies

Brazil’s drug regulator has published a new technical note updating guidelines on registration and post-registration procedures for biological products.

Dyes and colors which FDA says industries agree should no longer be used aren’t unsafe and are currently used only with the agency’s approval, industry stakeholders say. Center for Science in the Public Interest says the dyes are used “in tens of thousands of foods and beverages that are commonly consumed here in the United States.”

Lowell Zeta, a senior counselor at the FDA from 2020 to 2021, returns as deputy commissioner for strategic initiatives. The agency also names a new acting CIO and acting CVM director, but OGD's Ted Sherwood and OPDP's Catherine Gray retired.

HHS Secretary Kennedy commends food companies for cooperating, but also says, “We have them on the run now and we are going to win this battle. And four years from now, we're going to have most of these products off the market.”

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

HHS Secretary Robet F. Kennedy Jr. and FDA Commissioner Marty Makary to announce planned changes as “a major step forward” as part of Kennedy’s “Make America Healthy Again” campaign President Trump has adopted for his administration.

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

Mark Meador most recently worked as a visiting fellow at conservative think tank Heritage Foundation’s Tech Policy Center and worked during Trump’s first term as a trial attorney in the Department of Justice’s Antitrust Division. The two Democrat-appointee seats remain open while the members Trump recently fired contest his controversial decision.

Industry should be more vocal about the harms the recent reduction-in-force will have on getting drugs to market, NTEU Chapter 282 President Anthony Lee said in an interview with Pink Sheet.

Plan to reorganize the agency into five offices was designed by someone who does not understand the FDA, former long-time agency official Janet Woodcock says. The proposal would eliminate highly specialized expertise in favor of “a big team of generalists,” former Principal Deputy Commissioner Joshua Sharfstein says.