FDA Policy/General
The Trump Administration is considering White House health policy adviser Heidi Overton as a leading candidate to become the next FDA commissioner, according to Bloomberg reporting that cited people familiar with the selection process. No final decision has been made, and administration officials continue to evaluate candidates for the position.
FDA Policy/General
In the first of three planned online posts on FDA’s FY 2027 Appropriations Report, approved by the House Appropriations Committee to explain its agency funding bill, eight Hyman, Phelps & McNamara lawyers say the report “reflects a Congress eager to shape FDA’s regulatory priorities — from promoting artificial intelligence
FDA Policy/General
FDA acting chief of staff and deputy commissioner Lowell Zeta says the agency has secured 600 new employees and is looking to bring in another 1,600 as it works to recover from the massive staff cuts orchestrated in 2025 by the so-called Department of Government Efficiency. As reported
FDA Policy/General
A Skadden Insights post says the departure of former FDA commissioner Marty Makary and several of his senior executives has led to regulatory uncertainty in regulated companies. “Many of the initiatives that defined the Makary era were never enshrined in formal rules or guidance, but rather were announced by press
FDA Policy/General
Former FDA commissioner Scott Gottlieb is praising the agency's newly announced initiative to accelerate early-stage clinical trials, arguing that the package of reforms could help reverse the migration of Phase 1 studies to overseas markets such as China and Australia. Speaking on CNBC’s Squawk Box, Gottlieb
FDA Policy/General
HHS has launched a broad, department-wide initiative (Operation TrialBlazer) aimed at speeding clinical research, reducing regulatory barriers, and attracting more clinical trials back to the U.S. A centerpiece of the initiative is a new FDA proposal to establish a pilot program designed to shorten the timeline between drug
FDA Policy/General
Former FDA commissioner Scott Gottlieb is urging federal health officials to restore scientific leadership at the agency's medical product centers, arguing that recent political appointments and workforce losses have weakened the agency’s effectiveness and credibility. In a commentary published in JAMA Health Forum, Gottlieb said FDA has
FDA Policy/General
Two Mintz attorneys say recent leadership changes at FDA, coupled with many executive-level vacancies, have affected the priorities started by former commissioner Marty Makary. Writing in the one-year anniversary edition of their firm’s FDA in Flux newsletter, the attorneys say the leadership changes coincided with an immediate
FDA Policy/General
A coalition of 65 health, environmental, consumer, farming, and animal welfare organizations has filed a citizen petition urging FDA to withdraw approvals for the routine use of medically important antibiotics for disease prevention in food-producing animals. The petition argues that widespread antibiotic use in livestock contributes to the growing
FDA Policy/General
FDA and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) have unveiled a new liaison program designed to strengthen collaboration between the two regulators on medicines, medical devices and emerging technologies, including artificial intelligence. The initiative, announced Monday at the DIA Global Annual Meeting in Philadelphia, will
FDA Policy/General
Some 17 Senate Democrats have written to HHS secretary Robert F. Kennedy Jr. questioning many of his actions and decisions involving FDA and other health-related agencies that the senators say have “decimated our nation’s public health infrastructure and ability to quickly identify and respond to infectious disease outbreaks.
FDA Policy/General
FDA has issued Felix Pharmaceuticals an Emergency Use Authorization (EUA) for generic nitenpyram tablets to treat New World screwworm (NWS) infestations in dogs and cats, marking the first generic animal drug authorized for use against the parasitic pest. The authorization covers over-the-counter nitenpyram tablets for dogs, puppies, cats
FDA Policy/General
FDA has issued an untitled letter to contract manufacturer Formulated Solutions, citing GMP violations related to component testing and quality oversight at the company's Largo, FL, facility. In the 6/2 letter, FDA said its review of records submitted by the company in response to a September 2025
FDA Policy/General
Delegates at the American Medical Association's (AMA) annual meeting have voted to support stronger FDA oversight of synthetic peptide products, citing growing concerns about the widespread use of unapproved compounds marketed for weight loss, wound healing, longevity, and other health claims without robust clinical evidence. Peptides — short chains
FDA Policy/General
FDA's expanding use of artificial intelligence tools in regulatory operations is poised to transform how pharmaceutical, biotechnology, and medical device companies prepare for and manage inspections, according to a new analysis by former FDA Office of Enforcement director David Elder. In a guest column published on pharmaceuticalonline.com,
FDA Policy/General
Pharmaceutical Research and Manufacturers of America (PhRMA) is calling on FDA to provide clearer regulatory expectations for the use of digital health technologies in drug development, arguing that adoption has lagged despite years of agency guidance and industry investment. In comments submitted to an FDA request for information on advancing
FDA Policy/General
Drug manufacturers, patient advocates and policy experts used the first FDA public hearing on the Commissioner’s National Priority Voucher (CNPV) program to urge the agency to temporarily suspend the initiative and establish a more transparent framework governing its operation. The 6/4 hearing marked the first formal opportunity for
FDA Policy/General
The House, Thursday evening, passed FDA’s appropriations bill for fiscal year 2027 that provides $7.1 billion for the agency, including $3.4 billion in discretionary budget authority and $3.7 billion in authorized user fees. The measure was approved by a vote of 213 to 210. Meanwhile, Senate
FDA Policy/General
Former Oncology Center of Excellence and short-time CDER director Richard Pazdur says it’s time to restructure the agency’s organization into various new Centers. As reported by MedCity News, Pazdur appeared on a STAT panel during but apart from the recent annual meeting of the American Society of
FDA Policy/General
FDA has issued an untitled letter to QOL Medical, alleging that promotional emails for its rare-disease therapy Sucraid (sacrosidase) Oral Solution were false or misleading because they overstated the drug's benefits and omitted important risk information. In the just-posted letter, CDER’s Office of Prescription Drug
FDA Policy/General
FDA has issued a Warning Letter to Brazilian over-the-counter drug manufacturer Aeroflex Industria de Aerosol after the company failed to respond to multiple agency requests for manufacturing records related to drug products sold in the U.S. In a just-posted 5/22 Warning Letter, FDA said Aeroflex
FDA Policy/General
Senate appropriators have postponed consideration of a fiscal 2027 spending bill that would fund FDA, after a broader dispute over a Republican reconciliation package forced the Senate Appropriations Committee to suspend its markup schedule for the week. The Senate Appropriations Committee had been scheduled to meet 6/4 to mark