FDA Policy/General
FDA has accepted an AcelRx proposed plan to update certain promotional materials for its Dsuvia (sufentanil sublingual tablet, 30 mcg) in response to an agency 2/11 Warning Letter. The Warning Letter said a banner and tabletop display made false or misleading claims and representations about the drug’s risks
Devices
FDA says a Medtronic Vascular 5/4 recall of angiographic guidewire components is Class 1. The company says the recall was issued because the components were to be shipped to a third-party for further processing into kits and sterilization but instead were shipped directly to customers. Medtronic says some
Drugs
FDA has issued an immediately-in-effect guidance, Covid-19: Developing Drugs and Biological Products for Treatment or Prevention, to assist sponsors in the clinical development of drugs for treating or preventing Covid-19. The document does not apply to preventive vaccines and convalescent plasma. The guidance describes the agency’
FDA Policy/General
HHS secretary Xavier Becerra says there is no immediate rush to nominate an FDA commissioner and that the agency is fortunate to currently have acting commissioner Janet Woodocock at the helm. In a 6/16 interview with Bloomberg news, Becerra had this to say about the unfilled agency post: “So
Devices
FDA has cleared a NeuraLace Medical 510(k) for its Axon Therapy for stimulating peripheral nerves to provide chronic nerve pain relief. The device works by delivering focused magnetic pulses which activate the damaged peripheral nerve axons that are required to provide relief from chronic nerve pain. Its low frequency
FDA Policy/General
The Government Accountability Office (GAO) says its study of direct-to-consumer (DTC) drug advertising and Medicare spending on advertised drugs found it is hard to isolate the relationship between drug advertising, use, and spending. The report looked at drug manufacturer spending on DTC, Medicare spending on advertised drugs, and
Devices
CDRH has released for comment a discussion paper, “Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices: Challenges and Opportunities,” seeking input from groups and individuals outside FDA on the shared responsibility. Four areas identified in the paper are privileged access, identification of cybersecurity vulnerabilities and incidents, prevention and mitigation
Devices
Several Republican members of Congress, who are part of the Doctors Caucus on the Hill, are urging FDA to prioritize tests measuring the presence of T cell-mediated immunity to Covid-19. Tests measuring T cells could provide better detection of immunity in those naturally infected and could also be
Drugs
FDA has accepted for priority review a United Therapeutics NDA for Tyvaso DPI (inhaled treprostinil) for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease. The company says it expects a review decision in October. The submission includes data from the BREEZE clinical study that demonstrated
Drugs
Public Citizen says FDA acting commissioner Janet Woodcock, CDER director Patrizia Cavazzoni, and CDER Office of Neuroscience director Billy Dunn should resign or be dismissed over what the advocacy group calls the “reckless approval of aducanumab for Alzheimer’s.” Public Citizen calls for the three to leave the agency in
Devices
FDA has classified as Class 1 a recall of the Alaris Infusion Pump Module Model 8100 Bezel, purchased or installed by Infusion Pump Repair. Infusion Pump Repair is recalling the affected products and devices because the bezel components may crack or separate, leading to inaccurate delivery of fluids to patients.
Drugs
CDER director Patrizia Cavazzoni says areas of agency flexibility developed during the Covid-19 pandemic do not include changes to how the balance between a drug’s risks and benefits is determined. Responding to a question during a wide-ranging WebMD video interview, she said CDER continues to ensure that
Drugs
Drug company representatives say their experience with the FDA MIDD (Model-Informed Drug Development) paired meeting program has been strongly favorable. “The companies have recognized savings in resources, achieved alignment with FDA on developmental strategies, and gained clarity on important aspects of programs and product characteristics,” an open-source report
Drugs
FDA has authorized another vaccine drug substance batch (15 million doses) that was manufactured at troubled Emergent BioSolutions’ Baltimore facility for use in Janssen’s Covid-19 vaccine. The authorization follows last week’s sign-off on two other batches (10 million doses) from the same plant (see earlier story)
Drugs
The FDA regulatory system is “grievously and horribly broken” and there is no signal that it is getting better any time soon. That’s the perspective of University of California San Francisco associate professor of medicine Vinay Prasad. Writing in a hard-hitting online Medpage Today essay, Prasad says the
Drugs
FDA has issued a drug safety alert for alcohol-based hand sanitizers, warning that symptoms such as headache, nausea, and dizziness can occur after applying them. “These symptoms are likely to have occurred because of vapors from the hand sanitizer, potentially from exposure in enclosed spaces or places with poor
Drugs
Biogen says it has halted development of gosuranemab (BIIB092), an investigational anti-tau antibody that was being evaluated as a potential treatment for Alzheimer’s disease. Topline results from its Phase 2 TANGO study show gosuranemab did not meet its primary efficacy endpoint of change from baseline at week 78
Drugs
FDA has cleared a Neo Medical 510(k) for the use of its Pedicle Screw System in late stage tumor indications in combination with Osartis’ BonOs Inject cement. The clearance applies to the screws used at spinal levels where the structural integrity of the spine is not severely compromised, the
Drugs
FDA has started a five-year project with ConcertAI to evaluate real-world outcomes and safety in cancer treatment. The agreement is with CDER’s Office of Clinical Pharmacology and Office of Translational Science. An announcement says the collaboration builds on FDA’s program intended to explore the use of
Devices
Sen. Rand Paul’s Verified Innovative Testing in American Laboratories Act of 2021 (the VITAL Act of 2021) will lead to a better conversation on the regulation of laboratory-developed tests (LDTs) than could come from FDA actions. That’s the opinion of attorney Jeffrey Shapiro (Hyman, Phelps & McNamara)
FDA Policy/General
Federal Register notice: FDA is seeking comments on the use of study data exchange standards from stakeholders involved in study conduct, data collection, data management, and submission of animal study data intended to support the approval of new animal drug applications, abbreviated new animal drug applications, or applications for conditional
FDA Policy/General
Federal Register notice: FDA has announced that it received a petition requesting exemption from the premarket notification requirements for the generic device type: “powered patient transport, all other powered patient transport.” The products are motorized devices used to mitigate mobility impairment caused by injury or other disease by moving a