Devices
After 11 years at cloud and computer tech company Oracle, Troy Tazbaz has joined FDA as Digital Health Center of Excellence director, replacing Bakul Patel who left the agency last May to work for Google Health and its parent company Alphabet as senior director for global health strategy and regulatory
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Premarket Approval of Medical Devices.” The collection is being revised to include the burden associated with recommendations related to the guidance entitled “Providing Information about Pediatric Uses of Medical Devices.” It is also being revised related to
FDA Policy/General
Federal Register notice: FDA is announcing a 3/20 joint meeting of its Nonprescription Drugs and Anesthetic and Analgesic Drug Products advisory committees. Panel members are scheduled to discuss a Harm Reduction Therapeutics NDA for naloxone hydrochloride nasal spray, 3 mg/0.1 mL, for proposed nonprescription use as an
Drugs
Several public health advocacy groups have filed a lawsuit against FDA that challenges a 2021 denial of a citizen petition that sought the withdrawal of medically important antibiotics in livestock and poultry for disease-prevention or growth-promotion purposes. The petition included FDA’s own assessment that the antibiotics used
Devices
FDA has announced a new funding opportunity for its Pediatric Device Consortia grants program, which is open for applications through 3/29. Under the program, applicants request funding to serve as a nonprofit consortium to provide expert advising and support services to innovators of pediatric medical devices. “The advising and
Drugs
Janssen Pharmaceutical says it will seek FDA approval of a planned NDA supplement for Carvykti (ciltacabtagene autoleucel; cilta-cel) after announcing favorable data from its Phase 3 CARTITUDE-4 study evaluating the therapy versus pomalidomide, bortezomib, and dexamethasone or daratumumab, pomalidomide, and dexamethasone in patients with relapsed and lenalidomide-refractory
Drugs
Vanda Pharmaceuticals has petitioned FDA asking that it immediately revoke the approval of a TEVA ANDA for a generic copy of Vanda’s Hetlioz (tasimelteon) because Teva’s product fails to satisfy the same labeling and same conditions of use requirements. Hetlioz is indicated for treating non-24-hour sleep-
Drugs
FDA has denied a 3/2021 petition filed by Loeb & Loeb on behalf of an unnamed client that asked the agency to take specific actions concerning the adequacy of safety labeling for Incyte’s JAK inhibitor drug Jakafi (ruxolitinib) tablets. The petition asked FDA to open a public docket
FDA Policy/General
Rep. Anna G. Eshoo (D-CA) has been tapped as the ranking Democrat on the House Energy and Commerce Committee’s Health Subcommittee, which has primary oversight of FDA and other health agencies. During last Congress’ Democratic control, Eshoo served as chairwoman of the subcommittee. Now, with Republicans in control
Devices
LivaNova (TandemLife) has again recalled its LifeSPARC Controller, part of the LifeSPARC extracorporeal system used in heart surgeries, due to a problematic software update that was designed to address a previous software malfunction (see earlier story). The software update was found to create the same problem where the device erroneously
FDA Policy/General
Federal Register notice: FDA’s Office of Operations (OO), Office of Enterprise Management Services (OEMS) has modified its organizational structure, which was approved 9/26/2022 by HHS. The reorganization realigned the agency’s History Office function from the Office of the Commissioner, Office of External Affairs to OO, OEMS.
Drugs
FDA has granted Eli Lilly accelerated approval for Jaypirca (pirtobrutinib) for treating relapsed or refractory mantle cell lymphoma (MCL) patients who have had at least two lines of systemic therapy, including a BTK inhibitor. Approval was based on data from the BRUIN (NCT03740529) single-arm trial of pirtobrutinib monotherapy in
Drugs
Representative Brett Guthrie (R-KY) has been selected to serve as the House Energy and Commerce Committee’s Health Subcommittee chair for the current 118th Congress. The subcommittee has primary oversight of FDA and other health agencies. “My goal is to have a productive Health Subcommittee this Congress to ultimately
FDA Policy/General
A section of the Food and Drug Omnibus Reform Act (FDORA), which was passed by Congress at the end of 2022, requires sponsors of most drug and medical device clinical studies to submit a diversity action plan when they submit key trial documents to the agency. The requirement will apply
Drugs
FDA principal deputy commissioner Janet Woodcock says the agency has determined that current regulatory pathways are not appropriate for cannabidiol (CBD) products and it will work with Congress on a new cross-agency regulatory framework. In a statement, Woodcock says the need for a new framework was determined by a
FDA Policy/General
Federal Register notice: FDA has announced a 3/9 Oncologic Drugs Advisory Committee meeting to discuss a supplemental BLA for Polivy (polatuzumab vedotin-piiq) for injection. The submission proposes an indication for combination use with a rituximab product, cyclophosphamide, doxorubicin, and prednisone for treating adult patients with previously untreated diffuse
FDA Policy/General
Federal Register notice: FDA has issued a three-year debarment order against Poornanand Palaparty for providing services in any capacity to a person that has an approved or pending drug product application. FDA based the order on a finding that Dr. Palaparty, an oncologist, was convicted of a misdemeanor after
Biologics
FDA commissioner Robert Califf and CBER director Peter Marks say biological therapies should be subject to adequate randomized controlled trials (RCTs) before receiving FDA approval. Writing in Science Translational Medicine, Califf and Marks say the “reasons for requiring adequate, reliable evidence demonstrating that the benefits of a proposed intervention outweigh
FDA Policy/General
Two professors with academic appointments in the schools of public health at Johns Hopkins and George Washington universities say loopholes in FDA regulations on prescription drug promotion “are exposing American consumers to false and misleading claims of drug ads via online businesses promoting potent drugs without accurate information about their
Devices
The CDRH 2022 Annual Report shows that the Center granted marketing authorization for 19 submissions that were designated as breakthrough devices. The report also shows that 84 novel devices received marketing authorizations and there were 135 submissions designated as breakthrough devices. In terms of safety-related communications, CDRH was involved
Drugs
FDA says AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) is not currently authorized for emergency use against Covid-19 infection in the U.S. until further notice. An agency notice says data show Evusheld is unlikely to be active against certain SARS-CoV-2 variants that are projected to
Drugs
Emergent has recalled certain Reactive Skin Decontamination Lotion (RSDL) kits from a specific batch based on customer complaints about some packets leaking. An FDA recall notice says each kit contains a sponge soaked with lotion, and they are intended for military use to remove or neutralize chemical warfare agents and