Devices
FDA has cleared a Numares Health 510(k) for the Axinon LDL-p Test System, a test physicians can use to measure lipoproteins for patients at risk for cardiovascular disease. The clearance includes the company’s core technology platform, the Axinon System, which incorporates diagnostic testing algorithms into nuclear magnetic
FDA Policy/General
Federal Register notice: FDA is announcing the medical device user fee rates for fiscal year 2024. They are: * PMA, BLA or PDP: $483,560 * Efficacy Supplement (BLA) $483,560 * Panel-track supplement: $483.560 * De novo classification request: $145,068 * 180-day supplement: $72,534 * Real-time supplement: $33,849
FDA Policy/General
Federal Register notice: FDA has announced the rates for prescription drug/biologic user fees for fiscal year 2024. They are: * Application requiring clinical data: $4,048,695 * Application not requiring clinical data: $2,024,348 * Program fee: $416,734 To view the notice, click here.
Drugs
Democratic U.S. Senators Ben Cardin (D-MD), Tina Smith (D-MN), and Richard Blumenthal (D-CT) have introduced legislation that would give FDA and Centers for Medicare and Medicaid Services (CMS) additional authority to address drug shortages. The bill, the Drug Shortages Prevention and Quality Improvement Act (S 2586)
Devices
FDA says that it is expanding the medical device Total Product Life Cycle Advisory Program (TAP) pilot to include the Office of Neurological and Physical Medicine Devices beginning 10/1. The pilot, which began 1/1, was agreed to between FDA and industry as part of the reauthorization of the
Drugs
FDA has issued Citius Pharmaceuticals a complete response letter on its BLA seeking approval for Lymphir (denileukin diftitox), an engineered interleukin-2 diphtheria toxin fusion protein for treating patients with relapsed or refractory cutaneous T-cell lymphoma after at least one prior systemic therapy. The letter says that the company
Devices
Abbott says it has decided to stop selling its Trifecta heart valves due to the potential risk of early structural valve deterioration (SVD). Earlier this year, FDA issued a letter to healthcare providers about published literature suggesting a “higher cumulative incidence of early (five years or less) SVD for Trifecta
FDA Policy/General
Federal Register notice: FDA is requesting comments on an information collection extension entitled “Product Jurisdiction and Combination Products — 21 CFR Parts 3 and 4.” The collection supports FDA’s assignment of proposed combination products to the appropriate regulatory center. To view the notice, click here.
Biologics
FDA has posted a final guidance entitled “Assessing User Fees Under the Biosimilar User Fee Amendments (BUSFA 3) of 2022.” The document provides information on the types of user fees authorized by BsUFA 3, how FDA determines which products are subject to a fee, and FDA’s policies regarding exceptions
Devices
GE HealthCare has recalled its TruSignal SpO2 Sensors due to malfunction issues that may reduce defibrillation energy or expose patients to unintended voltage because of inaccurate readings. The skin-placed sensors are used to continuously monitor oxygen levels in the blood flowing through the arteries (arterial oxygen saturation or SpO2)
Drugs
FDA and Switzerland 7/27 have entered into a mutual recognition agreement (MRA) where each regulatory agency can rely on the other’s factual findings from a good manufacturing practice (GMP) inspection of a pharmaceutical manufacturing facility. The regulatory agencies signed the agreement 1/12, but it was contingent on
Drugs
FDA and the European Medicines Agency (EMA) have completed the first collaborative assessment of a proposed post-approval change for a critical cancer biologic with Japanese regulators serving as an observer. The collaboration resulted in approval for the undisclosed manufacturer to add new manufacturing and quality control sites for increasing
Drugs
A Government Accountability Office (GAO) review of FDA’s over-the-counter (OTC) drug monograph program performance based on enhancements provided by Congress in the 2020 CARES Act says that the agency has not begun receiving any OTC monograph order requests, and they do not expect to do so until
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection entitled “Voluntary Improvement Program (VIP)” that supports CDRH’s implementation of the program that is focused on promoting a culture of quality and organizational excellence. The Center says the VIP oversees third-party appraisers who evaluate industry participants
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder.” The document provides recommendations on designing pivotal clinical studies for such devices to support their marketing submissions. To view the notice, click here.
Devices
FDA has published a draft guidance, Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder, with recommendations for designing pivotal clinical studies of medical devices intended to treat opioid use disorder and used to support marketing submissions. The document’s recommendations apply to the design and development
Drugs
A Catalent facility in Brussels, Belgium, that fills syringes for Novo Nordisk’s weight loss drug Wegovy has had FDA compliance issues in recent years affecting product sterility. Reuters reports that it used a Freedom of Information Act request to obtain FDA inspection reports on the Catalent facility. The news
Drugs
FDA has told BioHaven that it will not review the company’s NDA for toriluzole to treat spinocerebellar ataxia because a Phase 3 study failed to meet its primary endpoint and thus the agency cannot perform a substantive review. The company says it is requesting a Type A meeting with
FDA Policy/General
Republican presidential candidate Ron DeSantis says there could be a place in his administration for Robert F. Kennedy, Jr., as either FDA administrator or CDC director, according to The Floridian. DeSantis, now governor of Florida, often highlights his views on the federal government’s response to the Covid-19 pandemic,
Drugs
Sen. Gary Peters (R-MI) has introduced bipartisan legislation, the Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act, to increase resiliency and readiness in the drug supply chain, easing drug shortages and preparing for future public health threats. A statement says the bill would require HHS to award contracts
Devices
Abiomed has recalled its Impella Left Sided Blood Pumps because the device’s “Instructions for Use (IFU)” do not adequately address precautions to take when treating patients who have undergone transcatheter aortic valve replacement (TAVR). “The IFU lacks guidance to clinicians on how to manage use of Impella in patients
Biologics
Merck says its investigational 21-valent pneumococcal conjugate vaccine V116 met key immunogenicity and safety endpoints in two Phase 3 trials. V116 was tested on vaccine-naïve and previously vaccinated individuals. The company says that if V116 is approved, it would be the first pneumococcal conjugate vaccine specifically designed for