FDA Policy/General
FDA has unveiled a new Transparency Roadmap that calls for expanded public disclosure of complete response letters, clinical study reports, inspection records and other regulatory information as part of a broader fiscal year 2027 transparency initiative. The roadmap builds on FDA’s 2025 initiative to publicly release complete response letters
Drugs
The FDA has granted fast track status to Trethera’s TRE-515 in combination with KRAS inhibitors for certain patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC). The designation covers TRE-515 combined with KRAS inhibitors for patients with G12C mutation-positive NSCLC previously treated with an
Drugs
FDA’s new commissioner, once confirmed and sworn in, should provide greater clarity on regulatory pathways for rare disease therapies, especially the use of single-arm clinical trials, a rare disease advocate argued in a new Washington Examiner commentary. David Gusick said uncertainty over FDA’s expectations could delay development
FDA Policy/General
FDA’s Office of Prescription Drug Promotion (OPDP) has cited Evolus over an Instagram promotion for wrinkle treatment Jeuveau (prabotulinumtoxinA-xvfs), saying the post exaggerated the drug's effectiveness and onset of action while minimizing serious risks. OPDP noted that it had raised similar concerns with Evolus in 2019
Drugs
FDA has cited Olympia Pharmaceuticals for eight observations involving aseptic processing, environmental monitoring, component testing and other manufacturing controls following an inspection last month at the company's Orlando, FL, outsourcing facility. The Form 483 said Olympia’s aseptic processing areas had deficiencies in environmental and personnel monitoring. Investigators
FDA Policy/General
While FDA is stepping up scrutiny of foreign clinical trials, particularly studies conducted outside an IND (see earlier story), drug sponsors should discuss their plans to rely on foreign data with FDA early in development, including at pre-IND meetings, and put greater emphasis on site selection, monitoring, investigator training
FDA Policy/General
The Committee to Protect Health Care has sent a letter signed by over 2,500 physicians to members of the Senate, urging them to reject the Trump administration’s nomination of Heidi Overton to be FDA commissioner. “Dr. Overton’s dangerous record on vaccines and extremist anti-abortion advocacy are
Drugs
Patient-safety advocate Suzanne B. Robotti is calling for stronger postmarket safety and drug-quality accountability measures to be added to the upcoming reauthorization of the brand and generic drug user fee programs. Writing in an 10/1 MedShadow opinion piece, Robotti said she urged FDA during September public meetings
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 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
Independent news and analysis of FDA regulation, policy and enforcement
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
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
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
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 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
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
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
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
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