#fda

#fda

Martin Marty Makary, one of the most prominent supporters of the Trump administration's Make America Healthy Again agenda, resigned as Food and Drug Administration commissioner. The reported decision came days after reports emerged that President Donald Trump had green-lit a plan to fire him. Makary was a surgical oncologist at Johns Hopkins University before Trump tapped him for the drug regulator's top job. His time at the helm of the FDA was marked by fierce battles over issues such as abortion and the aftermath of major layoffs at the agency.

He steps down after just over a year leading the powerful health regulatory agency, according to a White House official who was not authorized to speak before an official announcement and insisted on anonymity.

President Trump has signed off on a plan to fire Food and Drug Administration Commissioner Marty Makary, though insiders caution that the plan is not final and could change, according to several media reports. News of the planned axing comes from inside sources who spoke with The Wall Street Journal, which was then confirmed by reporting from Bloomberg, The Washington Post, and Politico. The Post reported that the administration has not decided who would serve as acting director upon Makary's departure.

FDA officials did not allow agency scientists to submit two abstracts for studies on Shingrix, a shingles vaccine, to a major drug safety conference. The studies reportedly bolstered known efficacy and safety data of the vaccines.

Utz Quality Foods announced a safety alert involving products sold under its Zapp's and Dirty brands, recalling nine varieties of potato chips due to potential salmonella risk.

Todd Blanche, the acting attorney general, signed an order that removes products sold under state medical cannabis licenses and FDA approved cannabis products from schedule I to schedule III, which includes legal but regulated substances. This change raises questions for the cannabis industry regarding its implications.

The U.S. Food and Drug Administration announced it is fast-tracking the review and approval process for three companies studying psilocybin, the active psychedelic compound in magic mushrooms, and methylone, an MDMA-like molecule, as treatments for depression and post-traumatic stress disorder (PTSD).

"Unfortunately, for patients and physicians in the melanoma community, we have had no choice but to stop our compassionate use program and adjust the planned expansion of our Phase 3 clinical program."

The recalled shellfish was harvested on March 22 through April 9, according to a safety alert from the FDA. The alert follows an April 10 recall conducted by the Washington State Department of Health, cautioning the FDA about all species of shellstock from the company, Gomez Shellfish, due to norovirus-like illnesses that were associated with the consumption of raw oysters.

The Trump-era patronage system has affected us all, by so often thrusting inexperienced randos with obvious political mandates into important positions that have previously always been occupied by career civil servants or specialized leaders.

Three types of cottage cheese sold under Walmart's Great Value brand are being recalled because they may not have been pasteurized properly. Containers of the Great Value Fat Free Small Curd Cottage Cheese, Lowfat Small Curd Cottage Cheese, and Small Curd Cottage Cheese were sold between February 17 and 20 with best by dates from April 1 to 3.

New analysis has identified 25 chemicals linked to cancer that the Food and Drug Administration ( FDA) still allows in American food production. The findings come from scientists at the Environmental Defense Fund (EDF), a nonprofit environmental advocacy group, who determined that eight of the chemicals are classified as known human carcinogens and 17 are reasonably anticipated to be human carcinogens.

The Food and Drug Administration is holding a public meeting Thursday to consider whether Philip Morris International can advertise its pouches as a less-harmful alternative for adults who currently smoke cigarettes. Government documents posted before the meeting suggest FDA regulators are leaning toward approving the company's request. But the meeting will give an outside panel of health experts a chance to weigh in and ask questions of both the company and the agency.

The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the agency, stoking worries that the plan may run afoul of legal, ethical, and scientific standards long used to vet the safety and effectiveness of new medicines. Marty Makary's program is causing new anxiety and confusion among staff already rocked by layoffs, buyouts, and leadership upheavals, according to seven current or recently departed staffers.

On Friday, Vinay Prasad-the Food and Drug Administration's chief medical and scientific officer and its top vaccine regulator-emailed a stunning memo to staff that quickly leaked to the press. Without evidence, Prasad claimed COVID-19 vaccines have killed 10 children in the US, and, as such, he announced unilateral, sweeping changes to the way the agency regulates and approves vaccines, including seasonal flu shots.

As of Wednesday, the Food and Drug Administration (FDA) said, 31 cases of suspected or confirmed infant botulism have been reported in babies who consumed ByHeart Whole Nutrition formula and got sick between August and mid-November. No deaths have been reported. But all 31 babies were hospitalized with the illness, which can cause a potentially life-threatening form of gradual paralysis in infants less than a year old.