Drugs
FDA says it is launching the Drug Risk Management Board, a “unified Center-level body that will ensure seamless alignment for marketed product safety activities among offices and will facilitate rapid analysis and resolution of drug safety issues.” An internal memo from CDER director Janet Woodcock says the board will
Devices
FDA has published a guidance, Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions, with recommendations for industry, systems and service providers, consultants, agency staff, and others on clinical performance assessment of computer-assisted detection (CADe)
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. CGA Limited Laventille, Trinidad & Tobago (12/19): FDA inspected the company in May and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to test
Biologics
FDA has approved a Horizon Therapeutics BLA for Tepezza (teprotumumab-trbw) for treating adults with thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards (proptosis). Approval was based on data from two
Drugs
The Government Accountability Office (GAO) has laid out six policy options in response to challenges it says hinder the adoption and impact of machine learning in drug development. The options are in a GAO report on artificial intelligence in health care undertaken in response to a congressional request. The report
Drugs
CDER says that the approved restructuring of the Office of New Drugs (OND) created offices that align interrelated disease areas and divisions with clearer and more focused areas of expertise. As a result, an online notice says, the names of the OND offices and divisions have changed. CDER says sponsors
Drugs
A 5/20-5/24/19 FDA inspection at Tismor Health and Wellness, Kingsgrove, Australia, found significant violations of current good manufacturing practice (CGMP) regulations in the firm’s work as a contractor producing finished drugs. A just-released 12/5/19 Warning Letter says specific violations were: * failing to
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Radioactive Drug Research Committees—21 CFR 361.1” (OMB Control Number 0910-0053). FDA has authority to establish radioactive drug research committees to approve and monitor basic research studies using radiopharmaceuticals. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Customer/Partner Service Surveys” (OMB Control Number 0910–0360). The collection covers customer/partner service surveys of regulated entities, such as food processors; cosmetic, drug, biologic, and medical device manufacturers; consumers; and health professionals. The request also
Devices
An 8/22-9/5/19 FDA inspection at CureWave Lasers, Dallas. TX, found that the firm is manufacturing the CureWave Medicore without an approved PMA or IDE in place. A just-released 12/12/19 Warning Letter says the firm’s device is misbranded because the company did not
FDA Policy/General
Federal Register notice: FDA is requesting that any consumer organizations interested in participating in selecting voting or nonvoting consumer representatives to serve on its advisory committees or panels notify the agency in writing. FDA is also requesting nominations for voting and nonvoting consumer representatives to serve on panels for which
FDA Policy/General
Federal Register notice: FDA has announced a 2/24 public meeting on “FDA Rare Disease Day 2020: Supporting the Future of Rare Disease Product Development.” The meeting is intended to obtain stakeholders’ perspectives on challenges and solutions in rare disease product development and identify commonalities that can support product development
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new information collection entitled “Empirical Study of Promotional Implications of Proprietary Prescription Drug Names.” The study is intended to give FDA insight into improving its proprietary name review that focuses on potential misbranding from names that overstate drug efficacy. To view
FDA Policy/General
CDRH Radiation Safety Panel Seeks Members Federal Register notice: FDA requests nominations for members to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee. 01/17/2020 Info Collection Extension for BLA Licensing Provsions Federal Register notice: FDA submits to OMB an information collection extension for BLA general
FDA Policy/General
DEVICES FDA has cleared a Nanowear 510(k) for its SimplECG, a remote cardiac monitoring undergarment. The device collects continuous multi-channel ECG, heart rate and respiratory rate data from the garment and transfers it to a Web-based portal for review by a physician through a mobile application. FDA
Drugs
FDA has approved a new indication for Novo Nordisk’s Ozempic (semaglutide) injection 0.5 mg or 1 mg — reducing the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or death in adults with Type 2 diabetes and known heart disease. The indication’s approval is
Drugs
FDA is seeking comments on new proposed research by CDER’s Office of Prescription Drug Promotion (OPDP) entitled “Empirical Study of Promotional Implications of Proprietary Prescription Drug Names.” The study is intended to give FDA insight into improving its proprietary name review that focuses on potential misbranding from names that
Drugs
FDA’s Anesthetic and Analgesic Drug Products Advisory Committee has delivered a split vote (6 to 6) on the approval of Durect Corp.’s Posimir (bupivacaine extended-release solution) with a proposed indication for administration into a surgical incision to produce post-surgical analgesia. Panel members recognized effectiveness and safety
FDA Policy/General
Federal Register notice: FDA is requesting nominations for members to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee. Nominations received after 3/17 will be considered for later vacancies. To view the notice, click here.
Devices
A new FDA safety communication recommends that hospitals and endoscopy facilities transition away from fixed endcap duodenoscopes to those with newer design features that eliminate the need or make it easier to reprocess. The devices are used in more than 500,000 endoscopic procedures associated with the pancreas and bile
Devices
Medtronic has issued an urgent field safety notice about the potential for navigational inaccuracy when its O-arm O2 Imaging System’s auto-registration feature is used in conjunction with an image-guided surgery system. “Medtronic has determined that replacement of the internal O-arm gantry tractor motor drive will
Drugs
Fusion IV Pharmaceuticals (dba Axia Pharmaceutical) has voluntarily recalled all unused sterile drug products within expiry due to a lack of sterility assurance. Administering a drug product that is not sterile could result in serious infections which may be life-threatening, a recall notice says. To date, the company says