FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says promotional materials for Sarfez Pharmaceuticals’ Soaanz (torsemide) tablets for oral use make false or misleading claims and representations about the drug’s efficacy and risks. A 4/25 Warning Letter cites agency concerns about the company’s Web pages, pamphlet, and
FDA Policy/General
Federal Register notice: FDA is announcing a 7/14 public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years 2028 through 2032. The current legislative authority for PDUFA expires in 9/30/2027, and new legislation will be required for
FDA Policy/General
Federal Register notice: FDA is hosting a 7/11 public meeting on the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years 2028 to 2032. The current five-year program will expire 9/30/2027 and new legislation will be required for FDA to continue to collect
FDA Policy/General
Restructuring drug user fee programs and bringing drug manufacturing and R&D home from offshore locations are primary objectives of the Trump Administration, according to newly appointed FDA deputy commissioner for policy, legislation, and international affairs Grace Graham. Addressing the Food and Drug Law Institute’s annual meeting 5/
FDA Policy/General
FDA has extended by two months its review of a PharmaTher NDA for Ketarx (ketamine) that is seeking anesthesia, sedation, pain, mental health, neurological, and medical countermeasures indications. The extension allows the agency more time to review information requests, which it has classified as a minor amendment, according to the
FDA Policy/General
FDA commissioner Marty Makary is set to testify 5/22 at a Senate appropriations subcommittee hearing on the agency’s fiscal year 2026 budget request. The White House earlier this month released its budget proposal, which included a significant overall reduction in non-defense discretionary spending, but specific details about
FDA Policy/General
In a 5/7 letter to HHS secretary Robert F. Kennedy, Jr., the Government Accountability Office (GAO) highlights open recommendations for FDA that it says warrant his attention. The letter particularly references a recommendation that HHS ensure effective FDA oversight. It says that protecting public health through enhanced oversight of
FDA Policy/General
An FDA 11/18-11/21/2024 inspection at the Taizhou Jingshang Cosmetics Technology Co. drug manufacturing facility in Taizhou, Zhejiang Province, China, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/3 Warning Letter says the specific violations were: * failure to
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a professional presentation for Mayne Pharma’s Nextstellis (drospirenone and estetrol tablets) for oral use makes false or misleading claims and presentations about the drug’s risks. A 4/28 Untitled Letter says the presentation speaker slide deck “creates a misleading
FDA Policy/General
FDA and HHS have launched a public Request for Information to “identify and eliminate outdated or unnecessary regulations.” An FDA statement says the initiative is part of a broader federal effort to reduce regulatory burdens and increase transparency in line with President Donald J. Trump’s Executive Order on “Unleashing
FDA Policy/General
FDA is preparing to begin negotiation sessions in September to reauthorize the Prescription Drug User Fee Act (PDUFA), which expires 9/2027. A new notice is seeking public stakeholders — patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts — to participate in periodic consultation meetings. The agency is
FDA Policy/General
Speakers at the recent DTC National conference on direct-to-consumer advertising suggested that despite calls for a ban on consumer advertising by HHS secretary Robert F. Kennedy, Jr., the odds of such a ban being implemented remain low. Representing the Healthcare Advertising Coalition, Jim Potter discussed the legal and
FDA Policy/General
Former FDA commissioners Scott Gottlieb and Mark McClellan say a plan circulated by the Department of Health and Human Services to restructure FDA by consolidating the product Centers that review drugs, biologics, animal health, medical devices, and tobacco into a single regulatory office would face many challenges. Writing in an
FDA Policy/General
FDA commissioner Michael Makary says the agency will expand the use of artificial intelligence (AI)-assisted scientific reviews across all Centers by 6/30. In a statement, he says the rollout follows the successful completion of a new generative AI pilot for scientific reviewers. “I was blown away by the
FDA Policy/General
The recent FDA reductions in force involving leadership, inspection administration, and travel logistical planners has been incredibly disruptive to the inspection cadre, but they do not rise to the level of disruption that was caused by the Covid-19 pandemic, former CDER Office of Compliance director (retired 2022) and now
FDA Policy/General
Theriva Biologics says its VCN-01 (zabilugene almadenorepvec) hit its endpoints in the VIRAGE Phase 2b trial using VCN-01 and standard of care (gemcitabine/nab-paclitaxel) as first-line therapy for patients with metastatic pancreatic ductal adenocarcinoma. A company statement says 48 patients treated with at least one dose
FDA Policy/General
Sen. Eric Schmitt (R-MO) has introduced legislation to create new inspectors general for FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health. In a statement, Schmitt says the Improving National Safety, Public Health, Ethics, and Clinical Trials (INSPECT) Act is needed because “Americans’ trust
FDA Policy/General
FDA associate commissioner for inspections and investigations Michael Rogers, who has worked for the agency for more than 30 years, is retiring effective 5/14, reportedly over staff frustration with commissioner Martin Makary. “I have decided to retire,” Rogers told CBS News. “It was my decision, but it was time
FDA Policy/General
FDA has tapped former Booz Allen Hamilton chief technologist Jeremy Walsh to lead its artificial intelligence (AI) and information technology efforts in a newly created leadership role — Chief AI Officer. Walsh announced his appointment via LinkedIn and it was first reported by Politico. Walsh served for 14 years as chief
FDA Policy/General
FDA has approved Teva Pharmaceuticals and Alvotech’s Selarsdi (ustekinumab-aekn) injection as an interchangeable biosimilar to Janssen’s reference biologic Stelara (ustekinumab) for treating psoriatic arthritis and plaque psoriasis, as well as Crohn’s disease, and ulcerative colitis. Ustekinumab is a human monoclonal antibody that selectively targets the p40
FDA Policy/General
FDA has appointed University of California, San Francisco professor and vocal FDA-industry critic Vinay Prasad to serve as CBER’s new director, replacing Peter Marks, who abruptly resigned last month rather than support what Marks described as HHS secretary Robert F. Kennedy Jr.’s “misinformation and lies” (see earlier
FDA Policy/General
Drug study information in NDAs/BLAs will need to be electronically submitted, beginning 12/2026, in a certain format to assist FDA in planning its bioresearch monitoring (BIMO) inspections, according to a just-posted agency Webinar. CDER says it uses the data and information described in a recent guidance to