Drugs
FDA has declined a Veru request for an Emergency Use Authorization (EUA) for sabizabulin, a microtubule disruptor for treating hospitalized adult patients with moderate to severe Covid-19 who are at high risk for Acute Respiratory Distress Syndrome. In a statement, the company said the agency’s decision was based
FDA Policy/General
FDA has approved an expanded indication for Eli Lilly’s Verzenio (abemaciclib), in combination with endocrine therapy (ET) for the adjuvant treatment of adult patients with hormone receptor-positive human epidermal growth factor receptor 2-negative, node-positive, early breast cancer at a high risk of recurrence. The expanded indication
Devices
FDA has cleared a FloSpine 510(k) for its a 3D-printed titanium Ti-Largo cervical interbody cage system to support the spine after a cervical collapse or a damaged disc has been removed and to restore height. The implants use titanium additive manufacturing (3D printing) and a patent-pending
Devices
FDA has cleared a Convatec 510(k) for its InnovaMatrix PD particulate placental extracellular matrix medical device for wound management. The product is made with Convatec’s proprietary TriCleanse Placental Extracellular Matrix Process, “which thoroughly decellularizes the [extracellular matrix] ECM, disinfects the tissue and deactivates viruses while maintaining structural proteins
Drugs
Exelixis says its Phase 3 CONTACT-03 study evaluating the company’s Cabometyx (cabozantinib) in combination with atezolizumab (Roche’s Tecentriq) versus cabozantinib alone in certain patients with renal cell carcinoma (RCC) did not meet its primary endpoint of progression-free survival (PFS). The study assessed patients who progressed during
Drugs
Federal Register notice: FDA is canceling for undisclosed reasons a 3/20 joint meeting of the Nonprescription Drugs Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee. Panel members were scheduled to discuss a Harm Reduction Therapeutics NDA for naloxone hydrochloride nasal spray, 3 mg/0.1 mL, for
Drugs
FDA has cleared a Bigfoot Biomedical 510(k) for the Android version of the Bigfoot Unity Mobile App, which is a part of the Bigfoot Unity Diabetes Management System. Because 41% of U.S. smartphone users choose Android devices, the clearance is intended to enable expanded access to those with
Devices
FDA has cleared a Noah Medical 510(k) for the Galaxy System, a robotic-navigated bronchoscopy device and accessories that are intended to provide bronchoscopic visualization and access to patient airways for diagnostic and therapeutic procedures. The company says the majority of cancerous lesions are located in the outer third
Drugs
The CDER Drug Safety 2022 Priorities Report highlights the Center’s activities involving Covid-19, the opioid crisis, drug overdoses, and efforts to improve the overall quality of compounded drugs. The report, the eighth in the series, also reviews the FDA Adverse Event Reporting System, Sentinel system, and the Safe
Drugs
CDER director Patrizia Cavazzoni says FDA and the Federal Trade Commission (FTC) are working together to help advance competition for biologics, including biosimilars and interchangeable biosimilars. Writing in an online FDA Voices post, Cavazzoni says the agencies’ commitments were detailed in a 2/3/2020 joint statement. That was followed
Drugs
The Sedgwick product safety and recall 2022 report, State of the Nation 2023, says that pharmaceutical recall events increased by 32.5% from 274 in 2021 to 363 in 2022. Comparably, medical device recall events went up 11.4% from 837 in 2021 to 932, the report says. Current good
Drugs
FDA has released the form FDA-483 issued following a 2/6-2/17 inspection at the Cipla sterile and non-sterile drug manufacturing facility in Madhya, Pradesh, India. The eight inspection observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of
Devices
FDA has rejected a request from Elon Musk’s Neuralink for permission to conduct human trials of a brain implant that Musk has said will ultimately make the paralyzed walk and the blind see. Reuters reports that the agency listed dozens of deficiencies that must be resolved before any approval
Drugs
U.S. Senators Maggie Hassan (D-NH) and Mike Braun (R-IN) have reintroduced their bipartisan bill to close a loophole that pharmaceutical companies can exploit to block drug competition, including generic drugs. The bill would restrict drug companies from patenting their Risk Evaluation and Mitigation Strategy (REMS) programs to
Biologics
FDA commissioner Robert Califf and CBER director Peter Marks are airing their disagreement with Children’s Hospital of Philadelphia Vaccine Education Center director Paul Offit over Covid-19 vaccine strategy in a series of letters in the New England Journal of Medicine. In a 2/9 Perspective, Offit cited preliminary
Drugs
The 2022 CDER Office of Generic Drugs (OGD) Annual Report outlines many highlights during the year, concurrent with the GDUFA 3 reauthorization. OGD approved or tentatively approved 914 ANDAs, participated in 108 pre-ANDA meeting requests, issued 257 product-specific guidances, issued 1,775 complete response letters detailing deficiencies before
Drugs
FDA has published a guidance, Q13 Continuous Manufacturing of Drug Substances and Drug Products, describing the scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). The document says it builds on existing International Council for Harmonization quality guidances to provide clarification on CM
Drugs
FDA has outlined new potential GMP issues under policy consideration in a discussion paper entitled “Artificial Intelligence (AI) in Drug Manufacturing.” The agency says difficulties could result from “potential ambiguity” on how to apply existing GMP regulations to AI or due to a lack of agency guidance or experience. The
Drugs
A jury has returned a $43 million verdict against Cameron-Ehlen Group, which does business as Precision Lens, for violations of the False Claims Act and Anti-Kickback Statute. During the six-week jury trial, the United States proved that the defendants paid kickbacks to ophthalmic surgeons to induce their
Drugs
A 5/2-5/16/22 FDA inspection at the Skyless LLC drug manufacturing facility in Ponce, Puerto Rico, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs and other violations. A just-released 1/23 Warning Letter says specific CGMP violations were: * failing to have,
Drugs
FDA has published a draft guidance, Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens, giving sponsors recommendations to assist in the development of monoclonal antibodies and other therapeutic proteins that directly target viral proteins or host cell proteins mediating pathogenic mechanisms of infection. The document
Drugs
CDER associate director for rare diseases Kerry Jo Lee says FDA is marking Rare Disease Day 2023 by exploring ways to engage and collaborate with patients, patient advocates, and other stakeholders to support the development of safe and effective therapies. Writing in an agency statement, Lee describes the Accelerate Rare