Drugs
A petition filed by a Charles Ludlam (identifying information redacted) asks FDA to (1) require that additional clinical trials of Novo Nordisk’s Ozempic/Wegovy (semaglutide) and Lilly’s Mounjaro/Zepbound (terzepatide) be conducted on the loss of lean muscle mass, setting the ideal goal weight for patients and maintenance
Drugs
FDA has granted MindMed a breakthrough designation for its MM120 (lysergide d-tartrate) program for treating generalized anxiety disorder (GAD). The designation comes as the company is announcing results from a Phase 2b study of MM120 in GAD that met its key secondary endpoint. Data also “demonstrated clinically and statistically
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should take a more flexible approach to implementing its proposed rule on patient medication information (PMI) by waiving the one-page format requirement when needed to include key information in a drug’s PMI. “Although complying with this strict page limitation
Drugs
FDA has accepted for review an Xcovery Holdings NDA for ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor for treating adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC). The submission is based on data from the Phase 3 eXalt3 study evaluating ensartinib vs crizotinib in the first-
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new proposed information collection entitled “Proposed Small Dispensers Assessment Under the Drug Supply Chain Security Act.” Under the Act, FDA is required to enter into a contract with a consulting firm with expertise to conduct a technology and software assessment that
Drugs
Par Pharmaceutical is recalling one lot of treprostinil injection 20mg/20mL (1mg/mL) due to the potential for the presence of silicone particulates in the product solution. The prostacyclin vasodilator is indicated for treating pulmonary arterial hypertension to diminish symptoms associated with exercise and for patients who require transition from
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new proposed information collection entitled “Proposed Small Dispensers Assessment Under the Drug Supply Chain Security Act.” Under the Act, FDA is required to enter into a contract with a consulting firm with expertise to conduct a technology and software assessment that
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products.” The document provides recommendations to nonprescription drug product applicants on documenting minor labeling changes in the next annual report. It also provides examples of minor labeling changes
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act.” The document identifies the information FDA generally considers to be necessary for cyber devices to support cybersecurity obligations under new amendments to the Federal
FDA Policy/General
Federal Register notice: FDA is announcing the renewal of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 1/22/2026. To view the notice, click here.
Devices
Hyman, Phelps & McNamara principal medical device regulation expert Adrienne Lenz and attorney Allyson Mullen say FDA should follow its 2/20 letter to the medical device industry urging companies to be aware of issues with fraudulent laboratory data with “practical guidance to help firms establish and maintain data integrity
Devices
A 9/18-9/26/2023 FDA inspection at the Exactech facility in Gainesville, FL, found Quality System and Medical Device Reporting regulation violations in the firm’s manufacturing of orthopedic implants and accessories. A just-released 1/19 Warning Letter says specific violations were: * failing to adequately establish procedures
Drugs
FDA has published a draft guidance, Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products, with recommendations for applicants for NDAs and ANDAs for nonprescription drug products on documenting minor labeling changes in the next annual report. The document also gives examples of such minor labeling changes.
FDA Policy/General
The Center for Veterinary Medicine (CVM) says promotional communications for Boehringer Ingelheim Animal Health USA’s Senvelgo (velagliflozin oral solution) make false or misleading claims and representations about the drug’s safety and effectiveness. A 3/1 Warning Letter says the violations are especially concerning from a public health perspective
Devices
FDA has published a draft guidance, Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the Federal Food, Drug, and Cosmetic Act, to propose select updates to the guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. The draft document says the agency intends to
FDA Policy/General
An FDA-funded 9/14/2023 virtual public workshop on “The Future of Prescription Drug Promotion and Digital Marketing” convened by the Duke-Margolis Institute for Health Policy identified three cross-cutting themes as described in the institute’s meeting report: * the pace at which new marketing venues, technologies, and
Devices
FDA and Instem researchers say their review of more than 10 million Medical Device Reports (MDRs) in the MAUDE (Manufacturer and User Facility Device Experience) database filed between 2011 and 2021 found that about 92% of reported issues represented medical device physical or functional failures rather than adverse events. Writing
Drugs
Pfizer says it plans to discuss with FDA data from its Phase 3 study of the antibody-drug conjugate Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab for treating patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The data showed a “statistically significant and clinically meaningful improvement
Drugs
Lexicon Pharmaceuticals says that after receiving recent FDA feedback it plans to resubmit its NDA for sotagliflozin oral tablets, 200 milligrams (mg) and 400 mg, as an adjunct to insulin therapy in patients with Type 1 diabetes and chronic kidney disease. In 2021, CDER issued a Federal Register notice proposing
Drugs
Acadia Pharmaceuticals says it is scrapping pimavanserin for treating negative symptoms of schizophrenia after announcing “disappointing” top-line results from the Phase 3 ADVANCE-2 trial. “Pimavanserin did not demonstrate a statistically significant improvement over placebo on the study’s primary endpoint, the change from baseline to week 26 on
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Early Alzheimer’s Disease: Developing Drugs for Treatment.” The document addresses drug clinical development for treating stages of sporadic Alzheimer’s disease that occur before the onset of overt dementia. It discusses the use of biomarkers reflecting underlying AD
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “FDA Adverse Experience Reporting for Licensed Biological Products; and General Records — 21 CFR Part 600.” The collection supports statutory and regulatory authorities that govern adverse experience reporting. To view the notice, click here.