Drugs
A 5/5-5/9/2025 FDA Bioresearch Monitoring Program inspection at Ashirwad Hospital & Research Center in Maharashtra, India, found that the facility and the clinical investigator, Mukesh Chandre, failed to obtain informed consent for a clinical in vivo bioequivalence study. A 4/29 Warning Letter acknowledges the corrective
Drugs
FDA investigators have cited multiple quality control and aseptic processing concerns at Staska Pharmaceuticals following a February inspection of the company’s outsourcing facility in Bennet, NE, according to a newly issued Form FDA 483. The inspection identified deficiencies involving visual inspection procedures, data integrity controls for laboratory testing and
FDA Policy/General
FDA has issued updated guidance outlining how drugmakers should design clinical development programs for new tuberculosis (TB) treatments, emphasizing the need for shorter, safer and more effective regimens as global drug resistance and HIV coinfection continue to complicate care. The guidance provides recommendations on trial design, safety evaluation and efficacy
FDA Policy/General
Eisai and Biogen say FDA has delayed by three months its decision on a subcutaneous starting-dose formulation of Alzheimer’s drug Leqembi (lecanemab) after the agency requested additional information during its review. The new review action target date for the supplemental BLA is 8/24. The application seeks approval
FDA Policy/General
A legal analysis published by Crowell & Moring says a proposed FDA pilot program on artificial intelligence in early-stage clinical trials could shape future agency expectations for how sponsors validate, document and oversee AI systems used in clinical research. In a Request for Information (RFI) issued this month, FDA
FDA Policy/General
President Trump is dismissing reports that say FDA commissioner Marty Makary will be asked to resign soon. Late Friday, Trump told reporters he knew nothing about Makary’s job being in jeopardy. The new week has brought no changes at the agency so far, and Makary continues to be authorizing
Drugs
FDA is seeking public input on ways to expand drug repurposing efforts, aiming to accelerate treatment options for patients with unmet medical needs by identifying new uses for already approved medicines. In an announcement released Monday, FDA said it is requesting information from patients, clinicians, researchers and other stakeholders on
Drugs
FDA has issued updated guidance for companies developing therapies to treat, prevent or reduce recurrence of Clostridioides difficile infection (CDI), outlining clinical trial expectations as the agency seeks to encourage new options for a disease that continues to cause serious illness and frequent relapse. The guidance covers development programs for
Drugs
FDA has released new guidance outlining how drugmakers should design and conduct postapproval studies evaluating the safety of medicines and biologics used during pregnancy, emphasizing the growing importance of real-world evidence and postmarketing surveillance in maternal-fetal health. The guidance, Postapproval Pregnancy Safety Studies, provides recommendations for sponsors and
Drugs
FDA has issued a new technical guidance document outlining how sponsors should submit continuous glucose monitoring (CGM) data collected during clinical trials for drugs and biologics, reflecting the growing role of digital health technologies in clinical research. The guidance, titled Submitting Continuous Glucose Monitoring Data in Clinical Trials, provides technical
Devices
Boston Scientific has begun a Class 1 recall (device correction) involving certain pacemakers and cardiac resynchronization therapy pacemakers (CRTP) following reports of device malfunctions linked to four deaths and more than 2,500 injuries. The action affects multiple models in the Accolade Family of Implantable Pacemakers and CRTP devices, including
FDA Policy/General
President Trump has reportedly signed off on a plan to remove FDA commissioner Marty Makary from his post, according to multiple media reports published Friday, potentially setting up another major leadership shakeup at the agency less than 14 months into the Trump administration’s second term. The Wall Street Journal
Biologics
FDA has approved a Partner Therapeutics BLA for Bizengri (zenocutuzumab-zbco) for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion whose disease has progressed following prior systemic therapy. The monoclonal antibody is designed to target the extremely rare and aggressive form of bile duct
FDA Policy/General
Atara Biotherapeutics says it and partner Pierre Fabre Pharmaceuticals have received feedback from FDA outlining a potential path toward resubmitting their BLA for tabelecleucel, an investigational T-cell therapy for Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). The companies recently held a Type A meeting with the
Drugs
The 4/14 CDER Compliance Program 7346.832M, “Prelicense and Preapproval Inspections of CDER-Regulated Biological Product Manufacturers,” which takes effect 5/14, provides a long-awaited framework and clarifies how FDA will evaluate commercial readiness, application commitments, CGMP compliance, and data integrity for both 351(a) and 351(k)
FDA Policy/General
FDA commissioner Marty Makary is reportedly in the White House’s crosshairs and could be removed from his post in the coming weeks as the Trump administration weighs a broader shakeup of key personnel, according to a 5/6 report published by journalist Rachael Bade on her Substack. Citing unnamed
Biologics
CBER acting director Katherine Szarama outlined an expansive vision for the biologics center during remarks at the Food and Drug Law Institute’s annual conference in Washington, DC 5/6, emphasizing regulatory flexibility, scientific rigor and increased engagement with industry as the agency confronts a rapidly expanding pipeline of complex
FDA Policy/General
Pharmaceutical advertising experts joined the Food and Drug Law Institute’s annual conference in Washington, DC 5/6 to share their reactions to FDA’s dramatically altered enforcement approach toward prescription drug promotion since last fall, creating new uncertainty for industry as the agency ramps up scrutiny of direct-to-
Drugs
Sanofi has reportedly asked FDA to remove its Type 1 diabetes therapy Tzield from the agency’s National Priority Voucher review program following an internal disagreement over the drug’s supplemental application, according to multiple media reports. The dispute centers on a proposed label expansion for Tzield to treat adults
Drugs
A Brookings Institution Center on Health Policy economist says he generally supports the approach FDA took in its draft guidance on New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act. The comment letter commends the agency for changes that clarify the
Drugs
In a report accompanying its appropriation bill that includes FDA, the House Appropriations Committee says it wants to prohibit FDA from accepting, reviewing, or considering clinical trial data gathered at sites in China, Russia, Iran, or North Korea that support drug or biologic INDs. Five Hogan Lovells attorneys write in
Drugs
FDA has released the form FDA-483 issued following a 2/10-2/21/2025 inspection at Somerset Therapeutics Private Limited, a Bengaluru, Karnataka, India, sterile drug manufacturer. The 10 inspection observations were: * failure to submit a Field Alert Report to FDA within three working days of receiving information concerning