FDA Policy/General
Church & Dwight is recalling (Class 1) all lots of Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, and Orajel Baby Teething Swabs due to potential microbial contamination identified as fungi in cotton swab components. “Swabs found to contain microbial contamination can potentially present a significant risk to the
FDA Policy/General
FDA commissioner Martin Makary and CBER director Vinay Prasad are listing five priorities for their vision of “a new FDA” that is based on gold-standard science and common sense. Writing in a JAMA Viewpoint article, the two say the agency “will transition from a purely reactionary healthcare system to
FDA Policy/General
After an 11-year stint at FDA, former regulatory counsel Jessica Ritsick has joined Alston & Bird’s FDA practice in Washington, DC., where she will counsel clients that design, manufacture, sell and distribute drugs, biologics, medical devices, food and other regulated products. During her career at FDA, Ritsick provided
FDA Policy/General
HHS says it is “totally reconstituting” the CDC’s Advisory Committee for Immunization Practices (ACIP), an advisory committee that makes recommendations on the clinical need of vaccines. The current 17 sitting ACIP members are being replaced with new members currently under consideration, HHS secretary Robert F. Kennedy Jr. says. “Today
FDA Policy/General
FDA commissioner Marty Makary has promised that the agency will listen to stakeholder ideas on reducing regulatory barriers and evolving its processes by “challenging deeply held assumptions on how we do things if it means we can deliver more cures and meaningful treatments, safe and effective to the American people.
FDA Policy/General
Three Morgan Lewis attorneys say FDA’s decision to use artificial intelligence (AI) to help agency reviewers should spur regulated companies to prepare to evaluate and respond to reviews that reflect AI input. Writing in an online post, the attorneys say that if the AI tool flags a concern or
FDA Policy/General
Two anonymous sources said to be familiar with the artificial intelligence (AI) tools FDA is rolling out to speed agency reviews and approvals tell NBC News the rollout may be moving too quickly. The sources said CDRH-GPT, still in beta testing in CDRH, is buggy, doesn’t yet connect
FDA Policy/General
A just-released FDA FY 2026 budget proposal shows that beginning 10/1 the agency’s overall budget would decrease by 4% ($271 million) to $6.8 billion. This includes $3.2 billion, an 11% or $400 million cut, in discretionary budget authority, and $3.6 billion in user fees,
FDA Policy/General
FDA 6/2 launched a generative Artificial Intelligence (AI) tool called Elsa that is designed to help employees — from scientific reviewers to investigators — work more efficiently. The agency is already using Elsa to accelerate clinical protocol reviews, shorten scientific evaluations, and identify high-priority inspection targets. The tool is built
FDA Policy/General
A recent notice of violation that was issued by the CDER Office of Prescription Drug Promotion (OPDP) to Mayne Pharma about a Nextstellis professional promotion is a reminder that OPDP puts as much energy into reviewing promotions targeting healthcare professionals as it does with direct-to-consumer promotions. That’s
FDA Policy/General
Democrats on the House Energy and Commerce Committee say HHS secretary Robert F. Kennedy, Jr.’s “silence on the widespread impacts of public health cuts is deafening.” In a 12-page 5/28 letter to Kennedy, the ranking members on the full committee and its Health and Oversight and Investigations
FDA Policy/General
GSK says it will submit an NDA in the second half of the year after it and Spero Therapeutics announced that they will end their Phase 3 PIVOT-PO clinical trial early following interim results that showed their oral antibiotic tebipenem HBr is effective in treating complicated urinary tract infections
FDA Policy/General
HHS secretary Robert F. Kennedy Jr. is continuing his verbal assault against the pharmaceutical industry, claiming that they control the nightly news content because of direct-to-consumer (DTC) advertising, which he says will be limited soon under his watch. During a 5/27-aired The Ultimate Human podcast, Kennedy
FDA Policy/General
Senator Dick Durbin (D-IL) has written FDA commissioner Marty Makary over concerns about how CDER’s Office of Prescription Drug Promotion (OPDP) can adequately regulate prescription drug advertising after the group was gutted by HHS reduction-in-force efforts and the recent departures of senior leaders (see story). “These
FDA Policy/General
[Commentary by James G. Dickinson] Like each of the past 15 FDA commissioners I have known since 1975, the current incumbent is both eminently qualified and dedicated to the agency’s mission. But unlike any of them, Martin Makary serves under the most science-defiant HHS secretary ever to hold
FDA Policy/General
Harvard University Department of Health Policy and Management professor Benjamin Sommers says Congress should use the current budget debate to “act as a brake on the administration’s layoffs. Current federal budget negotiations offer an opportunity for legislators who are concerned about the loss of expertise and investments in science
FDA Policy/General
Prothena says it will discontinue the development of birtamimab, its investigational treatment for AL amyloidosis, after the drug failed to meet the primary or secondary endpoints in a Phase 3 clinical trial. AL amyloidosis, which also known as immunoglobulin light chain amyloidosis, is a condition where abnormal protein deposits (amyloid)
FDA Policy/General
FDA has granted an expanded interchangeable designation for Celltrion’s Yuflyma (adalimumab-aaty), a high-concentration, citrate-free biosimilar copy of AbbVie’s Humira. Interchangeability now includes a prefilled syringe (40mg) and autoinjectors (40mg and 80mg). The designation permits pharmacists to substitute Yuflyma for Humira without requiring a new prescription
FDA Policy/General
Northern California federal judge Susan Illston has extended by two weeks a preliminary injunction halting the Trump administration’s plans for further reductions in force at FDA and 21 other federal agencies while the case is being appealed. The late 5/22 decision is in response to lawsuits filed by
FDA Policy/General
A Government Accountability Office (GAO) technology assessment report on human organ-on-a-chip (OOC) technologies says an issue facing the development of such technologies is unclear guidance and messaging from FDA. The report says OOC is an emerging technology that incorporates human adult cells in a small laboratory device
FDA Policy/General
A Friends of Cancer Research online analysis of data from the FDA accelerated approval (AA) program says it “remains a critical tool for expediting access to promising drugs in areas of unmet clinical need.” The majority of AAs (54%) ultimately receive full approval, the report says, with verification of benefit
FDA Policy/General
FDA has named Elizabeth Miller acting associate commissioner of the Office of Inspections and Investigations (OII), replacing Michael Rogers, who retired from the agency earlier this month after more than 30 years of service (see story). Miller recently served as OII deputy associate commissioner for medical products, overseeing OII’s