Devices
FDA WEBVIEW CLOSED FOR MLK DAY
FDA Webview’s newsroom will be closed Monday (1/18) in observance of Martin Luther King day. Nightly emails will resume 1/19.
David McFarland
Devices
Draft Guidance Recommends Device Cybersecurity Actions
A new FDA draft guidance is intended to help medical device makers address postmarket management of cybersecurity vulnerabilities. The document outlines important steps they should take to continually address cybersecurity risks to keep patients safe and better protect the public health. It also details the agency’s recommendations for monitoring,
FDA Policy/General
Comments Sought on Humanitarian Device Info
Federal Register Notice: FDA is seeking public comment on the information to accompany humanitarian device exemption (HDE) applications and the collection of information on the annual distribution number. Comments should be submitted by 3/15. To view this notice, click here.
FDA Policy/General
Vaccines Panel Renewed
Federal Register Notice: The FDA commissioner is renewing the Vaccines and Related Biological Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 12/31/17. To view this notice, click here.
Drugs
FDA Sponsoring Liver Injury, Dysfunction Conference
FDA and the Critical Path Institute are co-sponsoring a 3/23-24 public conference on “How Should Liver Injury and Dysfunction Caused by Drugs Be Measured, Evaluated, and Acted Upon in Clinical Trials?” A Federal Register notice says the conference’s purpose is to discuss, debate, and share views
FDA Policy/General
Guidance on Reducing Creutzfeldt-Jakob Disease
Federal Register Notice: FDA is making available a guidance entitled Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry. It provides blood collecting establishments and manufacturers of plasma derivatives with comprehensive recommendations
Drugs
Many Drug Trial Amendments Avoidable: Study
An analysis by the Tufts Center for the Study of Drug Development says that nearly half of drug trial substantial amendments are avoidable. Such amendments reduce the number of patients, and at a high cost and with longer study times, the analysis says in the latest Impact Report. “The incidence
Drugs
NIH Funds Antibiotic Alternative Development
The National Institutes of Health’s National Institute of Allergy and Infectious Disease is providing some $5 million in funding for 24 research projects at 18 academic institutions and three industry organizations seeking to develop non-traditional therapeutics for bacterial infections to help address the growing health threat of antibiotic
Devices
Activist Urges Mandatory Recall for Transvaginal Mesh
Barely a week after FDA ordered the reclassification of transvaginal surgical mesh for pelvic organ prolapse (POP) to Class III and the submission of safety-documented PMAs from their manufacturers, an activist claiming to represent thousands of mesh-injured women is urging the agency to recall the devices from the
Drugs
Drug Companies Exploring CRISPR
Drug companies are racing to determine whether the CRISPR (clustered regularly interspaced short palindromic repeats) gene-editing tool can help cure diseases, according to an online post in MIT Technology Review. A recently announced $300 million joint venture between Bayer and CRISPR Therapeutics to develop new drugs for blood disorders,
FDA Policy/General
FDA Making Progress on Clinical Trial Diversity: Buch
CBER associate director for medicine Barbara Buch says that the agency has taken “important steps to support the inclusion of diverse populations in clinical trials.” Writing in an FDA Voice blog post, Buch says the agency is implementing Congress’ directive in the FDA Safety and Innovation Act to look more
FDA Policy/General
Public Workshop on Genetic Test Results
Federal Register Notice: FDA will hold a public workshop 3/2: “Patient and Medical Professional Perspectives on the Return of Genetic Test Results.” Its purpose is to understand patient and provider perspectives on receiving potentially medically relevant genetic test results. The topic(s) to be discussed will focus on better
Drugs
FDA Accepts Adamis NDA Resubmission for Pre-filled Epinephrine
FDA has accepted for review an Adamis Pharmaceuticals NDA resubmission for its epinephrine pre-filled syringe product candidate for the emergency treatment of anaphylaxis. The resubmission addresses issues raised by an agency Complete Response Letter issued 3/2015. The letter raised questions on chemistry, manufacturing and controls (CMC) “related to
Devices
FDA Clears Conavi Medical Foresight ICE System
FDA has cleared a Conavi Medical 510(k) for the Foresight ICE System for intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy as well as visualization of other devices in the heart and great vessels. The company describes it as the first catheter-based ultrasound system capable
Drugs
Pay-for-delay Settlements Drop Substantially: FTC
The Federal Trade Commission says drug companies are entering into substantially fewer pay-for-delay patent dispute settlements than they were engaging in three years ago. According to a new FTC staff report, the follows a landmark Supreme Court antitrust decision in FTC v. Actavis in 2013. “The total number
Drugs
FDA Rejects Biomarin NDA for Kyndrisa
FDA has issued BioMarin Pharmaceutical Inc. a complete response letter on its NDA for Kyndrisa (drisapersen) for treating Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. The letter told that company that the agency has concluded that the standard of substantial evidence for the drug’s effectiveness has not
Devices
Changes Sought in Device Animal Study Guidance
Cook Group says that while an FDA draft guidance on general considerations for animal studies for medical devices is generally well written and reasonable in terms of the types of controls and level of detail that need to be specified in studies to develop valid scientific data, there are cases
Drugs
FDA Clears NeuroMetrix Upgraded Quell Pain Device
FDA has cleared a NeuroMetrix 510(k) for an upgraded version of Quell, the company's over-the-counter, drug-free chronic pain relief wearable device. The clearance covers the device’s controllability via the Quell Relief smartphone app. It also includes extended battery life and advanced sleep tracking.
Drugs
FDA Failing in Expedited Drug Safety Oversight: GAO
A Government Accountability Office report examining FDA’s expedited drug approval process in terms of postmarket drug safety found that “FDA lacks fundamental resources and leadership in ensuring that drugs brought to market quickly are truly safe and effective,” says Rep. Rosa DeLauro (D-CT), who requested the report. “If
FDA Policy/General
Docket Established on Clinical Outcomes Pilot
Federal Register Notice: FDA is establishing a docket to receive suggestions, recommendations, and comments from interested parties (including academic institutions, regulated industry, and patient groups) on its pilot “Clinical Outcome Assessment Compendium” (COA). Comments received on the pilot during its pilot phase will help FDA determine its utility, and may
Drugs
FDA Seeking COA Compendium Comments
FDA is seeking public comment on its pilot Clinical Assessment Outcome (COA) Compendium, which the agency says is part of efforts to foster patient-focused drug development. “The COA Compendium is intended to facilitate communication and to provide clarity and transparency to drug developers and the research community by collating
Drugs
Hospira, Celltrion Back Apotex in Biosimilar Appeal
Hospira and Celltrion have filed a friend-of-the-court brief with the Federal Circuit Court of Appeals supporting Apotex in its dispute with Amgen over when commercial marketing of biosimilars may begin. The companies say that a lower federal court misread the provision in the Biologics Price Competition and