FDA Policy/General
Referencing original reporting from the online health newsletter Stat, MSN says the White House is considering a final list of three contenders to be FDA commissioner — White House adviser Heidi Overton, oncologist and health system executive Jeffrey Vacirca, and Defense Department health affairs official Stephen Ferrara. The report says the
FDA Policy/General
FDA is preparing to formalize one of its most significant transparency initiatives in decades: the public release of Complete Response Letters (CRLs) issued to companies whose drug applications are rejected. An agency-planned rulemaking listed in the recent unified agenda as “Proactive Disclosure of Complete Response Letters,” would amend FDA
FDA Policy/General
FDA has issued Lundbeck Seattle Biopharmaceuticals an untitled letter alleging that promotional materials for its migraine therapy Vyepti (eptinezumab-jjmr) make unsupported efficacy and patient-reported outcome claims based on exploratory analyses and uncontrolled studies. The CDER Office of Prescription Drug Promotion (OPDP) letter targets two Web pages on Vyepti&
FDA Policy/General
FDA is planning to release a proposed rule in December that would require prescription drug advertisements on television, radio and similar broadcast media to include all relevant risk, contraindication and safety information within the advertisement itself, eliminating the longstanding option of directing consumers to outside sources for the information. The
FDA Policy/General
FDA briefing materials show that agency reviewers have found limited evidence supporting the safety and effectiveness of seven peptide substances that could become eligible for compounding by traditional pharmacies if they are ultimately added to the agency's Section 503A Bulks List. The reviewers generally found that the available
FDA Policy/General
The Alliance for Natural Health USA is suing FDA over the agency’s rejection of 114 health-related advertising claims for dietary supplements. Three Benesch Friedlander Coplan & Aronoff attorneys write in an online post that the Alliance claims that FDA’s interpretation of what counts as an “authoritative statement”
FDA Policy/General
Three candidates have emerged as finalists to become the next FDA commissioner, according to an Axios report citing sources familiar with the selection process. Axios reported that Heidi Overton, deputy director of the White House Domestic Policy Council; Jeffrey Vacirca, chief executive officer of New York Cancer & Blood Specialists;
FDA Policy/General
In annual observance of the Fourth of July (Independence Day) holiday in the U.S., the news operations of FDA Webview are closed until Monday, July 6. The next overnight email news bulletin from this site will be issued that evening.
FDA Policy/General
Speaking at the BIO 2026 convention, a panel of former FDA regulators praised the agency’s announcement of a pending IND pilot program as the potential start of a return to normalcy in policy making. The fact that the pilot was announced in an agency statement and solicited stakeholder feedback
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