Drugs
FDA is continuing to outline its intention to overhaul the early-stage clinical development process through a planned Expedited IND Pilot, arguing that the changes are needed to prevent drug development from shifting overseas and to accelerate first-in-human clinical trials in the U.S. In an 8/5
FDA Policy/General
FDA has finalized a guidance, Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern, that outlines a quantitative risk assessment framework for the agency to evaluate whether and to what degree a given antimicrobial drug used in food-producing
Drugs
FDA has issued a Request for Information (RFI) seeking feedback from industry, academia, healthcare providers, patient groups, and other interested parties on identifying critical community needs and establishing mechanisms for continuous engagement, supporting collaborative demonstration projects or research on innovative approaches aimed at addressing high-priority areas through the application
Drugs
Minutes of a Type C meeting between FDA and Tonix Pharmaceuticals show the agency and company aligned on the protocol for an adaptive Phase 2 study of Tonix’ TNX-4800 (human anti-outer-surface protein A monoclonal antibody) to prevent Lyme disease in adults. A company statement says the adaptive
Drugs
FDA has cited multiple manufacturing and quality system deficiencies at a Zydus Lifesciences Limited sterile manufacturing facility in Ahmedabad, Gujarat, India, including concerns related to aseptic processing controls, environmental monitoring, airflow studies and data review procedures, according to a just -posted FDA Form 483 issued following a 4/25-5/
Drugs
FDA has approved Takeda’s Orzeyful (oveporexton) tablets to treat narcolepsy type 1 in adults. An agency statement says Orzeyful is the first medicine approved for narcolepsy type 1 as a complete disorder, addressing the full range of symptoms that define the condition. It is the first drug to work
Drugs
Fresenius Kabi is recalling (Class 1) one lot of Simplist (morphine sulfate injection USP) 2 mg/1 mL prefilled syringes after discovering a labeling mix-up that could result in patients receiving hydromorphone. According to Fresenius Kabi, a MicroVault labeled as morphine sulfate injection 2 mg/1 mL may contain
Drugs
An FDA review of records requested from Thomas Brunner GmbH, a Baden-Württemberg, Germany, over-the-counter drug manufacturer, identified significant violations in the firm’s manufacturing of misbranded, unapproved drugs. A 7/24 Warning Letter lists these violations of the Federal Food, Drug, and Cosmetic Act: * failure to have,
Drugs
Jazz Pharma says it will seek FDA approval to remove Zepzelca’s (lurbinectedin) second-line metastatic small cell lung cancer (SCLC) indication based on data from the company’s LAGOON trial. In June, Jazz reported (see earlier story) that the confirmatory study failed to meet its primary endpoint of overall
Biologics
FDA has accepted for review an Allergan Aesthetics supplemental BLA for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of marked to very marked masseter muscle prominence (MMP) associated with masseter muscle activity in adults. “MMP can contribute to the appearance of a wider or more square lower
Devices
FDA has issued an early alert warning healthcare providers not to use certain Becton Dickinson (BD) intraosseous vascular access needle sets after the company identified a manufacturing defect that has been linked to delays in establishing emergency vascular access, including reports of four deaths and 45 serious injuries. The alert
Drugs
Liebel-Flarsheim is recalling (Class 1) one lot of its Optiray Imaging Bulk Package 350 radiographic contrast agent after identifying particulate contamination that could pose serious health risks if injected. A recall notice says the affected lot contains particulate matter identified as polyethylene and other plastic materials, stainless steel and
Drugs
The International Council for Harmonization (ICH) M8: Electronic Common Technical Document (eCTD) Implementation Working Group has issued updated support materials for eCTD v4.0. An ICH statement (contains links to the support materials) says the updates cover the implementation guide package, the controlled vocabulary package, and the Q&A
Drugs
Arrowhead Pharmaceuticals has agreed to acquire an FDA Rare Pediatric Disease Priority Review Voucher for $215 million from an undisclosed third party. The Pasadena, CA--based company says it intends to use the voucher for a supplemental NDA it plans to file before the end of the year to add
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it commends FDA for publishing a draft guidance on streamlining nonclinical safety studies for some oncology pharmaceuticals, particularly biologics and conjugated products. The association’s comment letter says issuance of the draft is a significant step toward implementing FDA’s Roadmap to
Drugs
A 1/12-1/16 FDA inspection at a Dabur India Limited drug manufacturing facility found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 7/24 Warning Letter says the specific violations were: * failure to establish an adequate quality control unit with the responsibility and
Devices
A 2/2-2/6 FDA inspection at Koven Technologies in St. Louis, MO, found Quality Management System Regulation (QSMR) violations in the firm’s production and/or marketing of the Bidop 3 Doppler. A just-released 7/21 Warning Letter lists these violations: * failure to document procedures to control
Drugs
FDA says it is undertaking a broad modernization of its inspection program, including expanded use of risk-based oversight, greater reliance on remote evaluation tools, and a sharp increase in unannounced inspections of foreign manufacturing facilities, according to a new post by senior agency officials. FDA associate commissioner for inspections
Devices
FDA has issued an updated final guidance entitled “Applying Human Factors and Usability Engineering to Medical Devices,” which describes current recommendations for applying human factors and usability engineering during the design and development of medical devices, revising a 2016 document to reflect changes in quality system requirements and current regulatory
Drugs
FDA has granted Eli Lilly a breakthrough therapy designation for olomorasib as a monotherapy for the treating adult patients with advanced pancreatic cancer who have received at least one prior systemic therapy and have a KRAS G12C mutation, as determined by an FDA-approved test. Olomorasib is described as an
Drugs
Sandoz has reached agreements totaling about $479 million to resolve most of its remaining exposure in long-running U.S. litigation alleging anticompetitive pricing practices in the generic drug market, while continuing to deny any wrongdoing. The company says its U.S. subsidiary has agreed to pay $400 million over
Drugs
FDA regulatory experts broadly praised the agency's new "Operation Trialblazer" initiative as an important step toward accelerating drug development but cautioned that lingering leadership turnover and regulatory uncertainty continue to weigh on investment in biotechnology, particularly in the cell and gene therapy sector. During the latest