Drugs
FDA has released a final guidance entitled “Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex (MAC): Developing Drugs for Treatment.” The document addresses clinical trial design issues, choice of trial population, and endpoints for the treating naïve and refractory NTM-PD caused by MAC. The agency notes that the
Drugs
FDA has released a draft guidance entitled “Post-Warning Letter Meetings Under GDUFA” that provides information on implementing the new program that was created during recent generic drug user fee negotiations. Such meetings are described as “a meeting with FDA regarding the facility’s remediation of deficiencies identified in a
Devices
FDA has cleared a 23andMe 510(k) to expand its existing BRCA1/BRCA2 (Selected Variants) Genetic Health Risk Report by allowing it to report an additional 41 variants known to be associated with higher risk for breast, ovarian, prostate and pancreatic cancer. “23andMe received the first FDA authorization for a
Devices
FDA says Universal Meditech has recalled all test products manufactured between 3/2021 and 11/2022 because the company is ceasing operations and is not able to continue fulfilling any post-market responsibilities for distributed products. Additionally, it says three products (PrestiBio Breastmilk Alcohol Test Strip, PrestiBio Ketone Test Strips
Biologics
Korea-based Hugel has resubmitted its BLA for its botulinum toxin Letybo (letibotulinumtoxinA), indicated for treating glabellar (frown) lines. The company received a complete response letter in April, and it says the resubmission addresses “facility management and supplementary work” that the agency's letter requested. Hugel expects a review
Drugs
Sage Therapeutics says it is reorganizing its business operations, including a 40% workforce reduction, to better support the expected launch of Zurzuave (zuranolone) to treat women with postpartum depression in late 2023. A company statement says the reorganization also will refine its pipeline development efforts to advance SAGE-718 and
Devices
Becton Dickinson says there are several things the Microbiology Devices Panel of the Medical Devices Advisory Committee should consider at its 9/8 meeting to discuss topics related to in vitro diagnostic devices used in pandemic preparedness and response. The company comment letter makes these recommendations for the panel’s
Devices
Datascope begun an FDA-rated Class 1 recall of its Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) because of “System Over-Temperature” alarms that require users to power down devices to allow cooling before therapy can be reinitiated. More than 9,000 pumps are affected. The recall
Devices
AdvaMed says HHS and other federal entities can take steps that are beyond the ability and resources of the medical device industry to increase patient access to at-home use of medical technologies. Commenting on an FDA request for information on the topic, the association says the government can help
Devices
FDA has cleared an Alcresta Therapeutics 510(k) for an expanded use of ReliZorb in children ages two to five years. ReliZorb is a digestive enzyme cartridge designed to mimic the function of pancreatic lipase. It was first cleared in 2015 for use in adults, and subsequently cleared in 2017
Devices
FDA has cleared a LivaNova 510(k) for its Essenz In-Line Blood Monitor (ILBM) that provides continuous measurement of essential blood parameters to perfusionists throughout cardiopulmonary bypass (CPB) procedures. The monitor is integrated into LivaNova’s next-generation CPB platform, the Essenz Perfusion System, which allows surgeons to access
Biologics
Four members of Congress from Michigan are calling on FDA to do more to stop the threat of bone graft infections across the U.S. In an 8/29 letter to FDA commissioner Robert Califf, Reps. John Moolenaar (R-MI) and Debbie Dingell (D-MI) and Sens. Gary Peters and
FDA Policy/General
FDA is reminding industry and others about its policy on using the “FDA” name and logo in any materials without being specifically authorized by the agency to do so. “Unauthorized use of FDA marks on private sector materials could send a message to the public that the FDA favors or
Drugs
FDA has published a white paper, “CDER’s Quality Management Maturity Program: Practice Areas and Prototype Assessment Protocol Development,” which discusses the assessment approach planned to be used at establishments participating in the Quality Management Maturity (QMM) program. The paper says the program’s goals are to: * foster a strong
Drugs
While progress has been made in many areas of FDA’s four-part drug overdose prevention framework, the crisis has grown into an even more dangerous public health challenge. That’s the assessment of FDA commissioner Robert Califf, in an online FDA Voices 8/31 post to mark International Overdose
Drugs
FDA has published a guidance, Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products, to discuss the applicability of the IND regulations to various clinical study designs that use real-world data (RWD). The document also clarifies
Drugs
FibroGen says its Phase 3 LELANTOS-2 trial of pamrevlumab for treating ambulatory patients with Duchenne muscular dystrophy did not meet the primary endpoint of change in the North Star Ambulatory Assessment total score from baseline to Week 52. Secondary endpoints (four-stair climb velocity, 10-meter walk/run test,
Devices
Hamilton Medical has recalled its Hamilton-C1, C2, C3, and T1 ventilators after receiving reports about software issues that may cause the devices to stop without notice. The ventilator will switch to “Ambient State” if the device is used for more than 91 days without a restart, according to a
Drugs
FDA has published a guidance, Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act, to assist supply chain stakeholders, particularly trading partners, with requirements for enhanced drug distribution security at the package level under Section 582 of the Federal Food, Drug, and Cosmetic Act.
Drugs
FDA has published two compliance policy guidances establishing a one-year stabilization period to accommodate the additional time that trading partners in the drug supply chain may need to adhere to Drug Supply Chain Security Act (DSCSA) requirements for electronic drug tracing at the package level. The requirements that were
Devices
Responding to an FDA call for public input, the American College of Cardiology says digital health is “transforming the practice of medicine. The demand and development of medical technologies for at-home use by patients has grown exponentially and has the potential to provide great opportunities to improve outcomes, drive
Biologics
FDA has renewed its funding for the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) under a new five-year $50 million cooperative agreement. A university statement says M-CERSI is a partnership between two University of Maryland campuses and is the oldest of the