Devices
CDRH has released its list of proposed guidances for FY 2027. The document separates the proposed guidances into three lists: * A List — priority guidance documents the Center intends to publish in FY 2027; * B List — guidance documents CDRH intends to publish as resources permit during FY 2027; and * Under Construction
Drugs
FDA has released the Form FDA-483 issued following an 8/20-8/28 inspection at Houston Rx, a Houston, TX, producer of sterile drugs. The 14 inspection observations were: * personnel performed aseptic manipulations with exposed hair or skin; * a pattern of frequent or acute pressure reversals was observed from
Drugs
FDA has posted an updated final guidance describing the international technical standard for electronically transmitting individual case safety reports, incorporating technical changes made to the ICH E2B(R3) implementation guide in 2025. The guidance, entitled “E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide — Data Elements and
Drugs
FDA has released the transcript of its 9/16 public meeting that outlined the Prescription Drug User Fee Act Agreement for reauthorizing the program for fiscal years 2028 through 2032. Under the agreement, the agency is proposing new mechanisms to reduce complete response letters, improve sponsor communications and address manufacturing
Drugs
HHS’ Advanced Research Projects Agency for Health has launched a funding initiative aimed at dramatically shortening clinical development of drugs and biologics through adaptive platform trials, artificial intelligence, and real-time data analysis. The “Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS)” program is seeking technologies and trial approaches
Drugs
Eli Lilly says its experimental combination of the amylin agonist EloraTZP (eloralintide and tirzepatide) produced greater weight loss and A1C reductions than high-dose tirzepatide (Lilly’s Zepbound ) alone in a Phase 2b trial of adults with obesity or overweight and Type 2 diabetes, prompting the company to advance the
FDA Policy/General
FDA says it is recruiting new agency advisory committee members who have scientific or consumer involvement in healthcare. An agency statement says advisory committees “are a cornerstone of FDA’s science-based, transparent regulatory process. These committees and panels bring together scientific experts such as physicians, researchers, biostatisticians, along with
Drugs
A 3/16-3/27 FDA inspection at Bentley Laboratories, a contract drug manufacturing firm in Edison, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs and other violations. A 9/17 Warning Letter says the specific CGMP violations were: · failure to thoroughly investigate any
Drugs
FDA has released the Form FDA-483 issued following an 8/24-9/8 inspection at Right Value Drug Stores, an Irving, TX outsourcing facility. The six inspection observations were: * failure to follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * failure of laboratory controls
Drugs
FDA has accepted for priority review a Roche NDA for fenebrutinib, an investigational non-covalent Bruton’s tyrosine kinase (BTK) inhibitor for treating relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The submission is based on data from the Phase 3 FENhance 1 and 2 RMS studies and
Independent news and analysis of FDA regulation, policy and enforcement
Pierre Fabre Pharmaceuticals (PFP) says its tabelecleucel BLA has been resubmitted with a proposed indication as monotherapy for treating adult and pediatric patients 2 years of age and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. PFP resubmitted
Aldeyra Therapeutics says it intends to submit a Formal Dispute Resolution Request to FDA, challenging a 3/16 Complete Response Letter that denied approval of the company’s NDA for reproxalap for treating dry eye disease. “Following an NDA submission and two NDA resubmissions of reproxalap for the treatment of
A 1/27-2/18 FDA inspection at the Fresenius Kabi USA drug manufacturing facility in Melrose Park, IL, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/22 Warning Letter says the three specific violations were: * failure to thoroughly investigate any unexplained discrepancy
FDA policy analyst and former HHS official Steven Grossman said FDA commissioner nominee Heidi Overton demonstrated at her confirmation hearing that she understands the agency must remain grounded in law, science and established regulatory processes, arguing that she could be a productive commissioner despite the difficult political environment she would
Five FDA drug company 2026 Warning Letters should be studied by other manufacturers who want to learn more about the agency’s position on documentation defensibility, according to a Quality Digest online post. The post says that in each of the five letters, that were issued within seven weeks, a
The U.S. Attorney’s Office for the Middle District of Florida and the Department of Justice’s Criminal Division have announced federal charges against Swapnadip Roy and Vicky Ramancha. The two Indian nationals have been charged with conspiracy and smuggling related to an alleged transnational counterfeit prescription drug distribution
Some 44 members of the congressional Democratic Women’s Caucus have written to FDA acting commissioner Kyle Diamantas and HHS secretary Robert F. Kennedy Jr., asking that they immediately address the ongoing shortage of estradiol transdermal patches that help manage menopause symptoms. A caucus statement (contains a link to the
The Senate has approved a House version of Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 (HR 8205) by unanimous consent. The bill, which extends the original ACT for ALS programs through fiscal year 2031 to maintain funding and access to investigational treatments, now heads to president
The Pharmaceutical Research and Manufacturers of America (PhRMA) board of directors have selected former House majority leader Eric Cantor as the group’s next president and chief executive officer. Cantor represented Virginia’s 7th Congressional District as a Republican from 2000 to 2014, serving as House Majority Leader from 2011
DBV Technologies has submitted a BLA for the VIASKIN Peanut Patch in children with a peanut allergy aged 4 through 7 years. The company says it requested a priority review for the submission. The patch uses epicutaneous immunotherapy, which the company describes as an innovative, non-oral, non-injection approach
A 1/28-2/5 FDA inspection at the Curia New York drug manufacturing facility in Rensselaer, NY, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A just-released 9/18 Warning Letter says the specific deviations were: * failure to have laboratory control