Devices
FDA has issued two final guidances on transition plans for Covid-19-related medical devices that were granted emergency use authorizations or were allowed to be marketed under the agency’s enforcement discretion policy. The guidances outline the agency’s general recommendations to transition from policies/operations implemented during the
Drugs
Oncology drug developers are encouraged to focus on randomized clinical trials, according to FDA recommendations in a 3/24 draft guidance entitled “Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics.” FDA Oncology Center of Excellence director Richard Pazdur is quoted in a release as saying: “Building quality and
Biologics
CBER’s Office of Therapeutic Products is hosting a 4/27 virtual public listening meeting to obtain input on methods and approaches (e.g., use of real-world evidence, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products. “The rapid pace of innovation for
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) says it is monitoring very closely the increasing use of social media platforms that promote prescription drugs. “The FDA takes its responsibilities seriously and will continue to monitor promotion and communications regarding prescription drugs through its surveillance operations, which include online platforms,
Devices
CDRH has launched a new Web page to discuss “mission-critical priorities of data and technology innovations” and provide information and resources on its Diagnostic Data Program. The page describes two focus areas: (1) Systemic Harmonization and Interoperability Enhancement for Laboratory Data, and (2) Digital Diagnostics: Over-the-Counter and
Devices
FDA has approved a Getinge PMA for its iCast covered stent system for treating patients with iliac arterial occlusive disease, which is a type of peripheral arterial disease caused by atherosclerosis. The company says iCast, which is sold outside the U.S. under the brand Advanta V12 covered stent, has
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says a recent FDA draft guidance on oncologic drug development provides limited information on how to optimize the dosage for oncology products that are developed for use in combination with other oncology therapies. In comments to FDA on its draft “Optimizing the Dosage
Drugs
FDA has issued Incyte a complete response letter for Jakafi (ruxolitinib) extended-release tablets, a JAK1/JAK2 inhibitor for once-daily use in treating certain types of myelofibrosis, polycythemia vera and graft-versus-host disease. Jakafi is currently approved in a twice-daily dosage. “The complete response letter states that
Drugs
FDA’s Peripheral and Central Nervous System Drugs Advisory Committee 3/22 voted 9 to 0 that Biogen’s amyotrophic lateral sclerosis (ALS) drug tofersen should be considered for accelerated approval. Panel members agreed that a biomarker assessed in tofersen’s clinical trial — a reduction in plasma neurofilament light chain
Drugs
FDA has published a framework that it says it will use to implement a multifaceted digital health technologies (DHT) program for drugs. The document notes that the PDUFA 7 commitment letter stating the agreements between the agency and industry for reauthorization of PDUFA, included goals relating to using DHTs to
Devices
FDA has added the Xtrava Health SPERA Covid-19 Ag Test to the list of tests expected to have a reduced performance with certain SARS-CoV-2 Omicron sub-variants. The Xtrava test was added to the FDA Web page on SARS-CoV-2 Viral Mutations: Impact on Covid-19
Devices
FDA-funded research conducted by the Smith Center for Outcomes Research at Boston’s Beth Israel Deaconess Medical Center has determined that newer unibody aortic stent grafts failed to outperform the older non-unibody devices through a median follow-up period of 3.4 years. A medical center media statement
Devices
FDA is reminding patients and healthcare providers about Exactech joint replacement devices that were manufactured between 2004 and 8/2021 and were recalled in 2021 and 2022. An agency notice says many of the Exactech knee, ankle, and hip joint replacement devices were packaged in defective packaging bags. “The defective
Drugs
Regeneron and Sanofi say a Phase 3 trial of Dupixent (dupilumab) evaluating the investigational use of the drug compared to placebo in adults currently on maximal standard-of-care inhaled therapy with uncontrolled chronic obstructive pulmonary disease (COPD) and evidence of type 2 inflammation met all key primary and secondary
Biologics
The Government Accountability Office (GAO) has published its review of the regenerative medicine and advanced therapies workforce in the commercial and academic sectors. The report was mandated by the Timely ReAuthorization of Necessary Stem-cell Programs Lends Access to Needed Therapies (TRANSPLANT) Act of 2021. The report has information on
FDA Policy/General
A White House Office of Science and Technology Policy report, “Bold Goals for U.S. Biotechnology and Biomanufacturing,” provides 10 goals that highlight what could be possible with the power of biology. “These goals are intended to provide a broad vision for the U.S. bioeconomy and what can be
Devices
CDRH director Jeff Shuren says one of the biggest concerns that keeps him up at night is medical device cybersecurity. Speaking at 3/23 Alliance for Stronger FDA Webinar, Shuren said the recent omnibus budget bill provided FDA with $5 million to finally build a desperately needed cybersecurity program. He
Drugs
FDA has approved a Cidara Therapeutics and Melinta Therapeutics NDA for Rezzayo (rezafungin for injection) for treating candidemia and invasive candidiasis in adults with limited or no alternative treatment options. The companies say this is the first new treatment option approved for these conditions in over a decade. Approval was
Drugs
FDA has issued AbbVie a complete response letter for ABBV-951 (foscarbidopa/foslevodopa) for treating motor fluctuations in adults with advanced Parkinson’s disease. The agency letter requested additional information about the product’s device (pump), the company says, adding that there were no requests to conduct additional efficacy and
Devices
FDA says events involving squamous cell carcinoma (SCC) in the scar tissue (capsule) that forms around breast implants should be reported to a registry developed by the agency, the American Society of Plastic Surgeons and the Plastic Surgery Foundation. The registry is the latest action to occur following a 3/
Drugs
FDA says its review of the Procter & Gamble drug listing information for its Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion determined that there is contradictory information between the labeling and the electronic listing file. A 3/14 Warning Letter refers the company to a 10/31/
Drugs
FDA has granted Incyte accelerated approval of its BLA for Zynyz (retifanlimab-dlwr), a monoclonal antibody targeting programmed death receptor-1 (PD-1) for treating adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). Approval was based on tumor response rate and duration of response (DOR), according to