Devices
FDA has approved a Cardiovascular Systems PMA for its ViperWire Advance Coronary Guide Wire with Flex Tip. The device is a combination of a flexible nitinol core with a shapeable floppy tip to help physicians navigate in complex anatomy, the company says. In addition, it says, the flexible nitinol body
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Amyotrophic Lateral Sclerosis (ALS): Developing Drugs for Treatment.” The document addresses the clinical development of drugs intended to treat the main motor aspects of ALS, i.e., muscle weakness and its direct consequences, including shortened life expectancy. It does
Drugs
FDA has placed a clinical hold on an Abeona Therapeutics planned Phase 3 clinical trial for EB-101 until it submits “additional data points on transport stability of EB-101 to clinical sites,” according to the company. “Over the last 12 months, the company has worked closely with the FDA
Drugs
University of Pennsylvania Abramson Cancer Center researchers say that within six months of an FDA move to restrict the labels of two immunotherapies, usage of the drugs among oncologists dropped about 50%. The researchers say the findings offer reassurance that oncologists “can be nimble enough to quickly incorporate the latest
Drugs
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Nutra Solutions USA, Deer Park, NY (9/12): FDA inspected the dietary supplement manufacturing facility in March and cited significant GMP violations.
Biologics
FDA has approved Bavarian Nordic A/S’s Jynneos smallpox and monkeypox vaccine, live, non-replicating, who are determined to be at high risk for smallpox or monkeypox infection. It is the only FDA-approved vaccine for preventing monkeypox disease. The agency says that Jynneos will be available for those
FDA Policy/General
Federal Register notice: FDA has made available a draft guide entitled “The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.” The program is authorized under the FDA Reauthorization Act of 2017 and the Medical Device User Fee Amendments of 2017. FDA believes the pilot may further encourage international harmonization of
Devices
FDA has released a draft guidance entitled “Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations.” The document is intended to help sponsors with how they can use patient engagement to understand experiences, perspectives, and other relevant information from patient advisors. It is also intended to improve
FDA Policy/General
FDA has posted a draft Guidance for Industry (GFI) #263, “Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter,” to help explain the recommended process for voluntarily changing the approved
Drugs
Rep G. K. Butterfield (D-NC) and the co-chairs of the Childhood Cancer Caucus, Reps. Michael McCaul (R-TX), Jackie Speier (D-CA) and Mike Kelly (R-PA) have introduced the Creating Hope Reauthorization Act. The measure would make permanent a priority review voucher program for pediatric rare disease
Devices
CDRH is seeking comments on its just-released “Health of Women Program Strategic Plan” that aims to “explore the unique issues related to the performance of medical devices in women, not only in the reproductive health space, but across a woman’s lifetime.” The plan focuses on three priority areas:
Drugs
FDA has made available a final guidance entitled “Wholesale Distributor Verification Requirement for Saleable Returned Drug Product — Compliance Policy.” The guidance announces a one-year delay in enforcement of a Drug Supply Chain Security Act (DSCSA) provision requiring wholesale distributors to verify a product identifier prior to further distributing returned
Drugs
FDA has issued a final guidance entitled Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment. The document provides FDA’s current scientific thinking so that, it says, effective treatments with a favorable benefit to risk profile can be most efficiently developed, studied and ultimately made available to patients. It was developed
Devices
FDA has approved Medtronic’s Evolut Pro+ Transcatheter Aortic Valve Replacement (TAVR) System. The device includes four valve sizes with an external pericardial tissue wrap that provides what the company describes as “advanced sealing for the largest indicated patient treatment range and the lowest delivery profile currently on the market.
Drugs
Federal Register notice: FDA has made available a draft guidance entitled “Interacting with the FDA on Complex Innovative Clinical Trial Designs for Drugs and Biological Products.” The document provides recommendations and discusses using novel trial designs, how sponsors may obtain feedback on technical issues related to modeling and simulation, and
FDA Policy/General
Comments Sought on Developing CNS Stimulants Federal Register notice: FDA seeks comments on development and evaluation of abuse-deterrent formulations of central nervous system stimulants. 09/20/2019 Device Guidances Under Safety/Performance Pathway Federal Register notice: FDA makes available several device-specific draft guidance documents for the agency’ device
FDA Policy/General
DEVICES Instrumentation Laboratory has received FDA 510(k) clearance of its ACL TOP Family 50 Series Hemostasis Testing Systems for mid- to-high-volume clinical laboratories, including those using lab automation tracks. According to the company, the systems offer automated pre-analytical sample integrity checks which identify under-filled sample
Drugs
Darmerica has recalled two lots of quinacrine dihydrochloride bulk active pharmaceutical ingredient (API) due to a label mix-up. Quinacrine is used as an antiprotozoal, antirheumatic, intrapleural sclerosing agent. The lots were tested and identified as artemisinin API, which is used for treating malaria. “Receiving artemisinin rather than quinacrine could
FDA Policy/General
Federal Register notice: FDA is seeking comments on development and evaluation of abuse-deterrent formulations (ADFs) of central nervous system stimulants and whether such products could play a role in addressing public health concerns related to prescription stimulant misuse and abuse. The notice also provides an overview of available postmarket
FDA Policy/General
Federal Register notice: FDA has made available several device-specific draft guidance documents for the agency’s device Safety and Performance Based Pathway. They are: Spinal Plating Systems — Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff; Cutaneous Electrode for Recording
Devices
FDA has released a draft guidance entitled Pilot Accreditation Scheme for Conformity Assessment Program that outlines goals, scope, procedures, and a suitable framework for the voluntary pilot, which was mandated by the FDA Reauthorization Act of 2017. The program is intended to support the agency’s continued efforts to use
Drugs
FDA has approved Novo Nordisk’s Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with Type 2 diabetes, along with diet and exercise. The agency says this is the first glucagon-like peptide (GLP-1) receptor protein treatment approved for use in the U.S.