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
Drugs
Six bipartisan House Energy and Commerce Committee leaders 1/17 wrote FDA commissioner Stephen Hahn seeking information on the agency’s processing of complex generic drugs. Their four-page letter said they were interested in lowering the costs of prescription drugs generally, but the number of complex generic drugs being
Drugs
TG Therapeutics has begun a rolling NDA submission for umbralisib, an oral, once-daily, dual inhibitor of PI3K-delta and CK1-epsilon for treating patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL). The company says it has requested accelerated approval after receiving guidance from the agency
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Form FDA 356h” (OMB Control Number 0910-0338). To view the notice, click here.
Devices
A new CDRH Learn module tells new manufacturers and importers about the FDA requirements for radiation-emitting products. In the Web video presentation, CDRH electrical engineer Lowell Howard reviews agency regulations and describes its role in regulating radiation-emitting electrical products. He says that manufacturers of radiation-emitting electrical products
Devices
FDA has announced a 3/5 public workshop entitled “Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine.” The workshop will discuss evaluation techniques for hardware, standards development, and assessment challenges for applications involving “extended reality (XR)” in medicine. Experts says that XR technologies, which
Drugs
Mindbreeze, described as a leading provider of appliances and cloud services for knowledge management, says it is working with the consulting firm Booz Allen Hamilton to deliver search capabilities for the CDER regulatory review community. “The intelligent Mindbreeze InSpire solution was successfully launched in October to provide broad search capabilities
Drugs
FDA has granted Arena Pharmaceuticals a fast track designation for APD418, a β3-adrenergic receptor antagonist and cardiac myotrope for treating decompensated heart failure. The company describes the selective antagonist as being designed to improve cardiac contractility with minimal effect on heart rate, blood pressure and myocardial oxygen consumption, thus
Drugs
FDA has denied an Otsuka 8/23/19 petition asking the agency to declare that its Samsca (tolvaptan) 60 milligram tablets were withdrawn for safety reasons. The petition also asked that FDA not approve any pending ANDA for generic Samsca and suspend and withdraw approval of any ANDA for a