FDA Policy/General
An FDA advisory committee 7/23 voted to recommend allowing several controversial peptides to be considered for inclusion on the agency's Section 503A Bulks List for pharmacy compounding, setting up a significant policy decision for the agency amid an ongoing debate over the safety and clinical evidence supporting
FDA Policy/General
FDA could remain without a Senate-confirmed commissioner for months as political and procedural hurdles complicate efforts to fill the agency's top post, according to an analysis published Wednesday by PharmaVoice. More than two months have passed since former FDA commissioner Marty Makary resigned, and the Trump administration
FDA Policy/General
One of the FDA items in the HHS recently published Unified Agenda would, if finalized, fundamentally reshape the landscape of prescription drug marketing in the U.S. Sheppard attorneys Dominic DiSabatino and Audrey Mercer write in their firm’s FDA Law Update that under the proposed rule, drug manufacturers would
FDA Policy/General
To be successful, FDA reform should involve a whole-of-system strategy centered on predictable, inflation-adjusted funding, protection of workforce memory, and renewed engagement with global regulatory and public health networks. That’s the view of a Cureus Journal of Medical Science editorial written by Arya Babul and Parisa
FDA Policy/General
The U.S. House of Representatives has passed the FDA Modernization Act 3.0 (H.R. 2821), advancing bipartisan legislation intended to accelerate the adoption of non-animal testing methods in drug development and align the agency’s regulations with changes Congress enacted four years ago. The bill, sponsored by
FDA Policy/General
FDA has issued an untitled letter to Sanofi Vaccines U.S., alleging that promotional emails for its respiratory syncytial virus (RSV) prevention product Beyfortus (nirsevimab-alip) were false or misleading because they overstated the drug's approved indication. In the letter, CDER’s Office of Prescription Drug Promotion (OPDP)
Drugs
Novo Nordisk has filed a Lanham Act suit in New Jersey federal court alleging that ads for Lilly’s GLP-1 drug Zepbound and Mounjaro (both tirzepatide) are deceptive because they reference outdated studies in an attempt to demonstrate the Lilly products are superior to Novo Nordisk’s Ozempic and
FDA Policy/General
FDA and the Department of Justice are increasingly extending enforcement actions beyond traditional drug manufacturers to telehealth platforms, online marketplaces, compounders and other companies involved in distributing FDA-regulated products, according to a former DOJ official. During an episode of the FDA Watch podcast, Gabriel Scannapieco, a partner at Arnold
FDA Policy/General
A 7/20 realclearhealth.com opinion article contends that FDA acting commissioner Kyle Diamantas has outlined a broad vision for modernizing the agency by emphasizing innovation, artificial intelligence, advanced manufacturing, and supply chain resilience while maintaining the agency's traditional standards for safety and effectiveness. The commentary, written by
FDA Policy/General
A new study suggests that direct-to-consumer prescription drug Web sites may better communicate the limitations of FDA accelerated approvals when disclosures use consumer-friendly language rather than technical wording drawn from physician labeling. The study, published 7/15 in Therapeutic Innovation & Regulatory Science, examined whether the presence,
FDA Policy/General
Quasi betting platform Kalshi has launched a pilot program allowing traders to buy and sell contracts tied to the outcomes of late-stage clinical trials and FDA regulatory decisions, creating what the company says will be the first publicly available, continuously updated probabilities for drug development milestones. The initiative, announced
FDA Policy/General
A group of prominent academic and public health experts is urging FDA to embrace greater transparency, scientific independence and regulatory consistency, arguing that public confidence in the agency has eroded amid concerns over political interference and shifting regulatory standards. In a commentary published Tuesday in Fortune, Jeffrey Sonnenfeld of the
FDA Policy/General
The prescription drug advertising industry is increasingly concerned that FDA is planning rulemaking that could effectively eliminate branded direct-to-consumer (DTC) television advertising by removing a longstanding regulatory provision governing risk disclosures. Earlier this month, HHS outlined plans to release a proposed rule in December that would require broadcast
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