FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.” The collection supports the agency’s compounding program that is intended to protect patients from unsafe, ineffective,
Drugs
A New Jersey federal judge has agreed with Amneal Pharmaceuticals and the Federal Trade Commission (FTC) that five Teva ProAir HFA patents should be removed from the FDA Orange Book. Reuters reports the judge agreed with Amneal and FTC that the Teva patents only cover parts of a “metered inhaler
Drugs
Two Morgan Lewis attorneys say a recent FDA draft guidance describing how it intends to implement the Platform Technology Designation Program “marks a continuation and expansion of efforts by Congress and FDA related to advanced manufacturing….” In an online post, the attorneys say the law and guidance define a platform
Drugs
Ultragenyx Pharmaceutical and Mereo BioPharma say there were positive results in the Phase 2 portion of the Phase 2/3 Orbit study of setrusumab in patients with the complex bone and tissue disease osteogenesis imperfecta (OI). A statement from the companies says treatment with setrusumab continued to significantly reduce the
Drugs
FDA has given traditional approval to Lilly’s Retevmo (selpercatinib) for adult and pediatric patients age two and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine refractory (if radioactive iodine is appropriate). An agency notice says Retevmo received accelerated
FDA Policy/General
A House Appropriations subcommittee 6/11 voted out a fiscal year 2025 budget for FDA that slashes President Biden’s recently requested agency funding by $450 million (6%). In March, Biden proposed $7.2 billion for FDA (see story), but now the subcommittee markup has only approved $6.75 billion,
Devices
FDA has cleared an Avicenna.AI 510(k) for its CINA-VCF, a triage and notification artificial intelligence tool for detecting unsuspected vertebral compression fractures (VCFs) in patients undergoing chest or abdomen CT scans. “Often resulting from the deterioration of bone structure (osteoporosis), VCFs can cause significant pain, deformity, and
Devices
FDA has cleared a Getinge 510(k) for its innovative clinical decision support software Talis +ACG (Advanced Clinical Guidance), which the company says is intended for use to help promote compliance with care protocols directly at the bedside in high acuity care environments. The clearance covers the company’s Talis-
Devices
FDA has cleared a Spinal Simplicity 510(k) for its Wolff’s Law Anterior Cervical Plate System. The device features “active compression,” which provides continuous 24/7 compression to assist in achieving spinal fusion, according to the company. It also features a low-profile plate to minimize tissue disruption, and
Drugs
An FDA review of records submitted by TCT Neutraceuticals SDN. BHD in Puchong, Malaysia, identified significant violations of current good manufacturing practice (CGMP) regulations in the firm’s manufacturing of over-the-counter drugs. A 6/5 Warning Letter says specific violations were: * failure to conduct at least one test
FDA Policy/General
Federal Register notice: CDER is announcing the Emerging Drug Safety Technology Meeting program, intended to provide stakeholders involved in pharmacovigilance (PV) activities an opportunity to meet with CDER staff to discuss their research, development, and use of artificial intelligence and other emerging technologies in PV. The Center says the program’
Devices
Insulet is recalling (Class 1) its Omnipod DASH Insulin Management System’s Personal Diabetes Manager after receiving reports of battery issues (e.g., swelling, fluid leakage and overheating). A recall notice warns that users could be exposed to battery fluid and extreme heat, and there is a risk for an
Drugs
A 9/12-9/21/2023 FDA inspection at the Cosmetic Solutions drug manufacturing facility in Boca Raton, FL, identified current good manufacturing practice (CGMP) regulation and unapproved new drug violations in the firm’s manufacturing of finished drugs. A just-released 5/31 Warning Letter says specific CGMP violations
Drugs
The FDA FY 2023 Office of Pharmaceutical Quality (OPQ) annual report says there were 776 drug quality assurance inspections, over 40% more than the 548 in FY 2022. In addition, it says, there were 187 mutual recognition agreement partner inspections, the highest number achieved to date. At the end of
Devices
FDA has published the three 2024 enhancements to CDRH’s electronic medical device reporting (eMDR) system. The page says the FDA eSubmitter client is updated concurrently with the eMDR system, but industry with system-to-system, or AS2, accounts with the FDA electronic submissions gateway should use the enhancement information
Devices
Medline Industries is recalling (Class 1) its Sub-G Endotracheal Tube with Subglottic Suction due to detachment or tearing of the inflation tube and other device components from the main tube. A recall notice says the device malfunctions could result in cuff leakage, deflation, moisture buildup, and failure to inflate.
Drugs
Biogen praises an FDA draft guidance on developing drugs to treat early Alzheimer’s disease and offers one comment on the diagnostic criteria for early Alzheimer’s and two comments on outcome measures. The company also provides line-by-line specific technical comments. In its response, Public Citizen says that
Devices
Writing in a JAMA Internal Medicine research letter, Israeli researchers say that despite a 2014 FDA guidance, women have been underrepresented in medical device clinical trials. The researchers say that CDRH recently issued a strategic plan for improving women’s representation in medical device trials. “We found that device trials
Drugs
FDA has granted Ipsen accelerated approval for Iqirvo (elafibranor) 80 mg tablets for treating primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Approval was based on data showing the therapy’
FDA Policy/General
Federal Register notice: FDA is announcing the renewal of its Arthritis Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 4/5/2026. To view the notice, click here.
Drugs
FDA is announcing an Emerging Drug Safety Technology Meeting (EDSTM) program to assist industry in implementing artificial intelligence (AI) capabilities in their pharmacovigilance (PV) activities. The program will provide stakeholders an opportunity to meet with CDER staff to discuss their research, development, and use of AI and other emerging technologies
Biologics
FDA has approved an expanded use for GSK’s Arexvy (respiratory syncytial virus (RSV) vaccine, adjuvanted) for preventing RSV lower respiratory tract disease (LRTD) in adults aged 50 through 59 years and who are at increased risk. The vaccine was previously approved for use in adults aged 60 and older.