Devices
AdvaMed says an FDA action plan on artificial intelligence/machine learning-based software as a medical device (SaMD) should clarify which aspects of the plan also apply to software in a medical device (SiMD). “We generally believe FDA should apply the same policies to SiMD as it does for SaMD
Devices
At the second MDUFA 5 reauthorization meeting between FDA and industry, held on 3/17, seven items were discussed. A meeting summary lists the items as: * Stakeholder feedback on MDUFA reauthorization from a 10/27/20 public meeting; * FDA perspective on MDUFA 4 performance, noting that the agency disagrees with
Drugs
Reps. Vern Buchanan (R-FL), Elaine Luria (D-VA), Nancy Mace (R-SC), Mikie Sherrill (D-NJ), and Brendan Boyle (D-PA) have introduced H.R. 2565, the FDA Modernization Act, to lift requirements for animal testing for any new drug development and to enable FDA to require the most
Devices
CDRH director Jeffrey Shuren says FDA has issued an amendment for many molecular diagnostic Covid-19 tests that had received an emergency use authorization. Under the amendment, if a test developer has self-certified it has validated its test for pooling, FDA will add that test to a list of
Drugs
Y-mAbs Therapeutics says it is collecting data from identified historical control groups sought by FDA for the company’s omburtamab, an investigational monoclonal antibody that targets B7-H3 and has been radiolabeled before intraventricular central nervous system administration. A company statement says the firm had a Type B meeting
Biologics
Agenus has submitted a BLA seeking accelerated approval for balstilimab, an anti-PD-1 antibody for treating patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The submission includes data from the company’s pivotal Phase 2 single-arm clinical trial, which demonstrate that balstilimab
Drugs
FDA has placed a clinical hold on an Anixa Biosciences ovarian cancer chimeric antigen receptor-T cell therapy (CAR-T) being developed in partnership with Moffitt Cancer Center (MCC), requesting additional information before allowing the trial to begin. Within the next 30 days, the company and MCC expect FDA will
Drugs
The DC Circuit Court of Appeals has affirmed in a 4/16 decision a district court decision that FDA is not afforded discretion when a combination product meets the definition of both a device and a drug. At issue in Genus Medical Technologies v. FDA was that having a product
Drugs
FDA’s decision earlier this month to recommend a pause on Johnson & Johnson Covid-19 vaccinations was more a move to cover agency rear ends than to protect public health, according to an opinion piece by Pacific Research Institute senior fellow and former FDA’s Office of Biotechnology director
Devices
Tenacore is recalling Alaris Pumps it serviced because the bezel repair posts may crack or separate leading to inaccurate delivery of fluids to patients. The separation of one or more bezel repair posts may result in free flow of fluids to patients, fluid over delivery or under delivery, fluid interruption
Biologics
Emergent BioSolutions, contract Covid-29 vaccine supplier to Johnson & Johnson, has agreed to halt production at FDA’s request and quarantine existing bulk ingredient material at its troubled Baltimore Bayview facility as it submits to an agency inspection that began 4/12. The agreement will be in place pending
Devices
FDA has sent Block Scientific a Warning Letter after reviewing the firm’s Web site (www.blockscientificstore.com) and determining it is marketing Covid-19 test kits without agency approval, clearance, or authorization. FDA also said the products are misbranded because Block failed to notify the agency of its intent
FDA Policy/General
Federal Register final rule: FDA is amending medical device classification regulations to exclude certain software functions from the definition of a device as mandated by the 21st Century Cures Act’s medical software provisions. The Cures Act amended the definition of a device in the FD&C Act to
FDA Policy/General
Federal Register notice: FDA is clarifiying that despite enforcement discretion efforts during the Covid-19 pandemic, Class 1 surgeon and patient examination gloves will continue to require premarket notification. Furthermore, because of the potential risks posed by gloves that have not undergone FDA’s premarket review, FDA intends to increase
Drugs
FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) for combination use with chemotherapy for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. An agency release says this is the first FDA-approved immunotherapy for the first-line treatment of gastric
Devices
Becton Dickinson has recalled (Class 1) its CareFusion 303 Alaris Pump Module because of the risk of the keypad lifting up due to fluid entry. The issue could lead to keys that become unresponsive or stuck, and this may lead to an infusion delay or interruption, a recall notice says.
Drugs
Eli Lilly has requested that FDA revoke its Emergency Use Authorization for bamlanivimab (LY-CoV555) 700 mg alone due to the growing prevalence of Covid-19 variants in the U.S. The company says it will now only provide bamlanivimab and etesevimab together for treating Covid-19. Lilly says it
Devices
FDA has granted Perimeter Medical Imaging AI a breakthrough device designation for its Optical Coherence Tomography Imaging System coupled with ImgAssist AI. The device is designed to offer advantages over existing alternatives for intra-operative evaluation of margins during breast cancer lumpectomy, according to the company. Perimeter says it is
FDA Policy/General
Federal Register notice: FDA has announced a 6/7-8 public workshop entitled “Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions.” The workshop is intended to bring stakeholders together to discuss the scientific basis of morphine milligram equivalents (MMEs) with the goals of providing an
Devices
CDRH director Jeffrey Shuren and Office of Product Evaluation and Quality director William Maisel say the Covid-19 pandemic has caused “unprecedented workload demands” on Center staff and resulted in delays in the Center’s “conventional” workload, including some tasks covered by MDUFA time commitments. Writing in an online post,
Drugs
Three Harvard University professors and two Zuckerman attorneys who used to work at HHS say FDA should use the GDUFA 3 reauthorization negotiations to “balance the need to ensure sustainability with the goal of providing a level playing field for competition among firms of all sizes.” Writing in Health Affairs,
Devices
FDA has selected Intertek as an accredited testing laboratory under the agency’s Accreditation Scheme for Conformity Assessment Pilot Program. With the selection, 12 affiliates within Intertek’s global lab network are authorized to help manufacturers around the world with medical device premarket testing to access the U.S market,