Drugs
CDER is requesting information for a planned regulatory science initiative to advance biomarker validation through the compilation of data from multiple sources and through a specific pilot project focused on aggregating data for biomarkers of drug-induced kidney injury. A 5/13 Federal Register notice says ultimately, improving CDER’s
Drugs
FDA says Ipsen will voluntarily withdraw its cancer drug Tazverik (tazemetostat) from the U.S. market after new clinical trial data showed an increased risk of serious secondary blood cancers in patients receiving the therapy. In a safety alert, the agency said treatment with Tazverik was associated with higher rates
Drugs
FDA has cited SCA Pharmaceuticals for multiple manufacturing and contamination-control deficiencies at its outsourcing facility in Windsor, CT, including failures involving sterile compounding practices, particulate contamination investigations and environmental monitoring. According to a just-posted FDA Form 483 issued following an inspection conducted in March, investigators found that procedures
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
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
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)
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
Drugs
Some 30 bipartisan members of the House of Representatives are calling on FDA to advance its evaluation of rapid-acting novel therapeutics, including entactogen and psychedelic-assisted therapies, to treat serious mental health conditions. In a letter organized by Reps. Jack Bergman (R-MI) and Lou Correa (D-CA) the
Drugs
FDA commissioner Marty Makary says the agency is undertaking a major hiring push and a series of operational reforms aimed at strengthening its scientific workforce, modernizing inspections and reversing what he described as a loss of U.S. leadership in early-stage drug development. Speaking at the Food and Drug
Drugs
FDA has released the form FDA-483 issued following a 1/7-1/17/2025 inspection at the Bio-Thera Solutions drug substance and drug product manufacturing facility in Guangzhou, Guangdong Province, China. The six inspection observations were: * failure to fully establish or follow procedures designed to prevent microbiological contamination
Drugs
FDA has awarded a Commissioner’s National Priority Voucher to Partner Therapeutics for its Bizengri (zenocutuzumab-sbco) to treat adults with advanced, unresectable, or metastatic cholangiocarcinoma harboring a neuregulin 1 gene fusion with disease progression on or after prior therapy. A company statement says it submitted a BLA to FDA
Drugs
FDA has published a guidance, Chemistry, Manufacturing, and Controls Flexibilities for Developing a Human Cellular and Gene Therapy Product for a Biologics License Application, describing how the agency applies flexibility to the chemistry, manufacturing, and controls (CMC) requirements for human cellular and gene therapy (CGT) products being developed for BLAs.
Drugs
FDA will convene a virtual public meeting later this month to address industry questions tied to a planned pilot program exploring the use of artificial intelligence in early-stage clinical trials. The 5/15 virtual session will focus on an agency request for information seeking stakeholder input on how AI-
Drugs
FDA is reaffirming support for decentralized clinical trials (DCTs) while making clear that moving trial activities outside traditional research sites does not reduce sponsor accountability, according to new client alert from Crowell & Moring. In updated guidance, the agency signaled that decentralized elements — such as telehealth visits, home-based care,
Drugs
During a CNBC interview at a 5/4 Milken Institute conference, FDA commissioner Marty Makary forcefully defended the agency against mounting criticism of recent drug rejections, arguing the agency is “following the science” while accelerating broader reforms aimed at speeding approvals and restoring U.S. biotech competitiveness. Makary pushed back