Devices
FDA is announcing a 9/29 virtual public workshop entitled “Patient-Reported Outcomes and Vision-Related Quality of Life Questionnaires,” which is intended to highlight the importance of patients’ perspectives, patient-reported outcomes (PROs), and questionnaires to measure visual function and vision-related quality of life (VFQs) in vision research
Drugs
FDA has reportedly issued Novo Nordisk a Form FDA-483 that cites GMP deficiencies at its Clayton, NC, manufacturing plant, which is a key facility for making its diabetes and weight-loss drug semaglutide (trade names Ozembic and Wegovy). The agency action was reported by Marketwire News and picked up
Devices
FDA has cleared a B. Braun Medical 510(k) for its AQUAbase nX Reverse Osmosis System. The single-stage device is intended for use in providing high-quality water for dialysis patients without the use of chemicals. It is designed to provide up to a 75% raw water conversion rate
Devices
CDRH has developed a Digital Health Frequently Asked Questions (FAQ) Web page to help developers bring innovative technologies to market. The Center encourages developers to contact its Digital Health Center of Excellence (DHCoE) throughout the development process with questions about digital health regulatory considerations. If after a developer has reviewed
Devices
FDA has cleared a Beacon Biosignals 510(k) for the Dreem 3S, a wearable headband with integrated machine-learning algorithms to capture electroencephalogram (EEG) data from the brain to monitor sleep architecture and aid in the diagnosis of disturbed sleep. The device allows patients to participate in clinically validated, EEG-
Drugs
FDA has approved a GlaxoSmithKline NDA for Ojjaara (momelotinib) for treating intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythaemia), in adults with anemia. Ojjaara is described as a once-a-day, oral JAK1/JAK2 and activin A receptor type 1
Biologics
FDA has issued a draft guidance entitled “Labeling for Biosimilar and Interchangeable Biosimilar Products.” The agency says the document’s recommendations for biosimilar and interchangeable biosimilar product labeling pertain only to the prescribing information, except for certain recommendations in Section V (FDA-Approved Patient Labeling of Biosimilar and Interchangeable Biosimilar
Biologics
FDA has extended by 90 days its review of an Iovance Biotherapeutics BLA submission for lifileucel, a tumor infiltrating lymphocyte therapy for treating patients with advanced (unresectable or metastatic) melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy. The accelerated approval submission’s review
Devices
FDA has published a guidance, Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program, to describe agency policy in participating in the program. The document says the Voluntary Improvement Program (VIP) is a voluntary program facilitated through the Medical Device Innovation Consortium that evaluates the capability
Devices
FDA has published a guidance, Breakthrough Devices Program, describing policies the agency will use to implement sections of several laws that authorize that program. The document supersedes one issued on 12/18/2018. The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products
Devices
FDA has granted Attune Medical a de novo marketing authorization for its ensoETM device and its use to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures. “This de novo authorization gives electrophysiologists a solution to proactively cool the esophageal wall during ablation procedures…,” the
Biologics
FDA has published a guidance, Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989, to give information to applicants that are required to report annually on the status of postmarketing studies and clinical trials for human drug and biological products
Drugs
FDA has made exploring how artificial intelligence (AI) can play a role in its regulatory operations a top strategic goal of its just-released four-year information technology strategic plan. It calls for the agency to “(d)rive exploration and address impacts of emerging technologies and trends such as AI
Devices
FDA has published two draft guidances on testing of medical devices with indications associated with weight loss. An agency statement says that when finalized, the guidances are intended to provide: * recommendations for non-clinical testing to support premarket submissions for these devices; * recommendations about clinical study design for the devices;
Drugs
The Federal Trade Commission has issued a policy statement, which is supported by FDA, warning brand-name pharmaceutical companies that they could face legal action if they improperly list patents in FDA’s Orange Book. “Improperly listing patents in the Orange Book may harm competition from less expensive generic alternatives
Drugs
FDA has approved updated labeling for Merck’s Temodar (temozolomide) under Project Renewal, an Oncology Center of Excellence program to update labeling information for older oncology drugs to ensure the information is clinically meaningful and scientifically up-to-date. An agency statement says it is the second drug to receive
Drugs
FDA has issued a safety clarification about its 9/12 Non-prescription Drug Advisory Committee deliberation and 16 to 0 vote (see story) that current scientific data do not support the effectiveness of the over-the-counter monograph dosage of orally administered phenylephrine (10mg) as a nasal decongestant. In the
Drugs
Zydus Pharmaceuticals submitted a 9/14 petition asking FDA to take certain actions concerning Indocin (indomethacin) suppositories, 50 mg, and its generic equivalent. The petition says the International Conference on Harmonization (ICH) standards and established drug product impurity acceptance criteria should be followed by ANDA sponsors and applicants, given the
Drugs
FDA and Rocket Pharmaceuticals have reached an agreement on a pivotal Phase 2 trial of the company’s RP-A501 to treat Danon Disease. Rocket CEO Gaurav Shah says the investigational gene therapy infusion “has the potential to restore normal cardiac function and provide a lifetime of benefit to patients
Drugs
Eiger Pharmaceuticals says it is discontinuing the Phase 3 LIMT-2 study of peginterferon lambda in patients with chronic hepatitis delta based on a recommendation from the trial data safety monitoring board. The board recommended on 9/7 that the trial be discontinued due to observations of four patients with
Drugs
The Supreme Court is likely to decide at the beginning of its term in 10/2023 whether to hear Shire’s appeal from an 11th Circuit Court of Appeals decision in a case involving state failure-to-warn law and the Highlights section of a drug’s labeling. That’s
Biologics
The International Society for Pharmaceutical Engineering (ISPE) says FDA should incorporate the concepts and terms in the International Council for Harmonization Q12 guidance on technical and regulatory considerations for pharmaceutical product lifecycle management in an FDA draft guidance on manufacturing changes and comparability for human cellular and gene therapy products.