Drugs
FDA says its 2/27 review of the Web site maintained by LyfeUnit found that the company is marketing in interstate commerce misbranded and adulterated ketamine products. A 6/23 Warning Letter says the agency has identified significant risks with unapproved ketamine products, especially in the absence of appropriate medical
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
Drugs
With FDA using its artificial intelligence (AI) tool ELSA during inspections, regulated companies can better prepare for inspections by using their own AI tool. That’s the view of former FDAer David Elder. Writing in a Med Device Online guest column, Elder says using ELSA enables an FDA investigator to
Drugs
FDA has released the form FDA-483 with three observations from a 4/20-5/04 inspection at the QuVa Pharma outsourcing facility in Sugar Land, TX. The specific inspection observations were: * failure to establish and follow written procedures to prevent microbiological contamination of drug products purporting to be sterile;
Drugs
FDA has granted Vera Therapeutics an accelerated approval for Trutakna (atacicept-vymj) to reduce proteinuria in adults with primary immunoglobulin A (IgA) nephropathy who are at risk of disease progression, providing a new treatment option for patients with the chronic kidney disease. The once-weekly subcutaneous injection’s approval was
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&
Drugs
Saol Therapeutics has resubmitted its NDA for SL1009 (sodium dichloroacetate, or DCA), an investigational treatment for pyruvate dehydrogenase complex deficiency (PDCD), a rare and life-threatening mitochondrial disorder with no currently approved therapies. The resubmission follows additional analyses requested by FDA after the agency issued a Complete Response Letter (CRL)
Devices
FDA has released the draft MDUFA Performance Goals and Procedures agreed to by CDRH and CBER under the MDUFA renewal of 2027. “Both FDA and the industry are committed to the spirit and letter of the goals described in this letter,” the document says. The specific goals and procedures are
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
Drugs
The HHS Inspector General (IG) has issued an advisory opinion that favorably addressed a drug manufacturer’s program to provide free antibody testing to determine whether it would be appropriate to prescribe the manufacturer’s product. Attorneys Dominick DiSabatino and Audrey Mercer (Sheppard) write in an online post on their
Biologics
Former CDC chief medical officer Debra Houry said she left the agency after concluding she could no longer defend its scientific integrity, citing widespread political interference in vaccine policy, communications, and data operations, according to a 7/5 CBS News interview aired on Face the Nation. The interview provides a
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”
Biologics
FDA has published a guidance, Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral, and Blood Product Management in Response to an Ebola Disease Outbreak, notifying blood collection establishments of the agency’s determination of Ebola to be a transfusion-transmitted infection. The document includes the agency’s recommendations for
Drugs
A 1/12-1/22 FDA inspection at the Excelvision – Fareva drug manufacturing facility in Annonay, France, found repeat significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/25 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexpected discrepancy or failure
Drugs
A 1/12-1/20 FDA inspection at the Genzyme Ireland facility located in County Wexford, Ireland, documented significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/22 Warning Letter says the specific violation was the failure of the firm’s quality control unit to
Devices
FDA says the Abiomed 5/18 recall of certain Impella CP Sets with SmartAssist is Class 1. An agency notice says Abiomed reported that specific distributed units of Impella CP with SmartAssist do not meet design specifications. “This out-of-specification may result in low purge pressure events from the
Devices
FDA says the Insulet 5/26 recall of certain Omnipod Pods is Class 1. An agency notice says Insulet identified that some pods from specific lots may have a small tear in the cannula just above the skin, between the Pod and the point where the cannula enters the body.
Drugs
FDA has selected seven companies to participate in the FDA PreCheck Pilot Program, an initiative it says is intended to boost American global competitiveness, strengthen domestic drug manufacturing, and improve the resilience of the U.S. drug supply chain. An agency statement says the pilot was launched 2/1 in
Drugs
FDA has published a guidance, Submitting Next-Generation Sequencing Data to the Division of Antivirals, with the agency’s current thinking about the submission of next-generation sequencing (NGS) protocols, data, and analysis supporting resistance assessments for developing antiviral drugs. The document says the provision of comprehensive and accurate resistance
Drugs
FDA has approved Orca Biosystems’ Tregzi (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq) suspension, for intravenous infusion, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adults with blood cancers undergoing allogeneic hematopoietic stem cell transplantation.
Drugs
A 12/3-12/10/2025 FDA inspection at the Wizcure Pharmaa Private Limited drug manufacturing facility in Rajasthan, India, fund significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/24 Warning Letter says the specific violations were: * failure to ensure that laboratory records included