Drugs
FDA says it is continuing to evaluate the risk of suicidal thoughts or actions in patients taking glucagon-like peptide-1 receptor agonists (GLP-1 RAs) such as Novo Nordisk’s Ozempic and Wegovy and Lilly’s Mounjaro and Zepbound. An agency drug safety update says its preliminary evaluation does
Drugs
The Washington Legal Foundation (WLF) says an FDA draft guidance on communications from firms to healthcare providers about scientific information on unapproved uses (SIUU) of approved/cleared medical products “threatens to undermine public health” and also “disregards the Constitution.” The WLF comment letter says the draft would chill truthful, non-
Devices
FDA has cleared a Zeta Surgical 510(k) for its Zeta Cranial Navigation System. The mixed reality surgical navigation system is intended to provide neurosurgeons “GPS-like” guidance with millimetric accuracy in real time, according to the company. “Zeta’s computer vision engine ensures maintained accuracy by automatically registering multiple
Drugs
Busse Hospital Disposables has recalled its Tracheostomy Care Tray, Dressing Change Tray, and Tracheostomy Care Set in response to Nurse Assist’s 11/2023 recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP due to sterility concerns. Busse says that the Nurse Assist saline is
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Requests for Reconsideration at the Division Level Under GDUFA.” The document provides recommendations on the procedures for ANDA applicants that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled Electronic Records; Electronic Signatures — 21 CFR Part 11.The collection supports statutory and regulatory authorities that govern criteria for accepting electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records. The
Drugs
FDA says its review of records submitted by South Korea’s Woorilife & Health, registered with the agency as a manufacturer of over-the-counter drugs, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 12/28/2023 Warning Letter says the specific violations were:
Devices
A 5/15-5/19/23 FDA inspection at Neitz Instruments Company in Ichibancho, Japan, found Medical Device Reporting (MDR) issues in the firm’s manufacturing of the Neitz Halogen Ophthalmoscope BXa. A just-released 8/25/23 Warning Letter says Neitz failed to develop, maintain, and implement written Medical
Drugs
A 9/23-10/12/23 FDA Bioresearch Monitoring Program inspection of two clinical trials led by Dr. Jeffrey Taub at Children’s Hospital of Michigan found “objectionable conditions,” according to a just-released 12/19/23 Warning Letter. The letter says it appears that Taub did not adhere to
Drugs
A California state appeals court has issued a split ruling in a case involving Gilead Life Sciences and 24,000 plaintiffs in a coordinated proceeding who say they suffered adverse effects from their use of the company’s tenofovir disoproxil fumarate (TDF) to treat HIV/AIDS. The decision says the
Drugs
FDA has published a draft guidance, Request for Reconsideration at the Division Level Under GDUFA, with recommendations on the procedures for ANDA applicants who want to pursue a request for reconsideration within the review discipline at the division level or original signatory authority. The document says that requests within its
Drugs
FDA says the Clinical Trials Transformation Initiative has published a report of its findings from a collaborative project with the agency to understand the barriers to timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov. In the report, CTTI documented the
Drugs
FDA has revised its guidance entitled “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile” to update the lists of established sterilization methods. It also provides details about the pyrogenicity information that is recommended for sponsors to include in a 510(k)
Drugs
Alcon has announced “positive topline results” from two pivotal Phase 3 clinical trials (COMET-2 and COMET-3) evaluating the efficacy and safety of AR-15512 for treating the signs and symptoms of dry eye disease (DED). “In both COMET-2 and COMET-3, which enrolled more than 930 dry
FDA Policy/General
Federal Register notice: FDA is announcing the issuance of a priority review voucher to Takeda Pharmaceuticals for its qualified rare pediatric disease product application — Adzynma (ADAMTS13, recombinant-krhn), indicated for prophylactic or on-demand enzyme replacement therapy in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura. To view the
FDA Policy/General
Federal Register notice: FDA is announcing the issuance of a priority review voucher to Amryt Pharmaceuticals for its qualified rare pediatric disease product application — Filsuvez (birch triterpenes), indicated for treating partial thickness wounds in patients six months and older with junctional epidermolysis bullosa and dystrophic epidermolysis bullosa. To view the
Drugs
FDA has granted Sellas Life Sciences a fast track designation for SLS009 (formerly GFH009), a highly selective CDK9 inhibitor for treating relapsed/refractory acute myeloid leukemia (AML). The designation is based on topline Phase 2a data that showed SLS009 in combination with venetoclax and azacitidine have “anti-leukemic effects with
Drugs
FDA has launched a new search function on its Office of Pharmaceutical Quality Web page to improve access to drug quality resources and online content. The new search Web page queries existing guidance documents, manuals of policies and procedures, and compliance programs to provide users with up-to-date resources
Drugs
FDA issued a 1/4 complete response letter on the Astellas Pharma BLA for zolbetuximab, an investigational treatment for patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive. A company statement
Drugs
CBER director Peter Marks says the benefits of chimeric antigen receptor T-cell (CAR-T) therapy far outweigh the risks involved, including secondary T-cell malignancies. Speaking 1/8 to the Alliance for Regenerative Medicine State of the Industry briefing, Marks said that while FDA issued a safety advisory for
FDA Policy/General
A staff announcement from CDER director Patrizia Cavazzoni says that FDA commissioner Robert Califf has selected Elizabeth “EJ” Jungman to be his chief of staff. She is currently the director of the CDER Office of Regulatory Policy (ORP). Cavazzoni said the new appointment “is a recognition of EJ’s broad
Devices
FDA says healthcare professionals and facilities should be aware of the potential for exposure to certain chemicals that may be released when the General Electric HealthCare EVair or EVair03 compressors are used with certain ventilators. An agency notice says the compressors are optional accessories for ventilators and are used when