Devices
A 10/14-10/17/19 FDA inspection at Mandelay Kft, Tokol, Pest, Hungary, found Quality System Regulation violations in the firm’s manufacturing of the Scientific Consciousness Interface Operation system and the Quantum University Energetic System Technology 9 devices. A just-released 2/3 Warning Letter says specific violations
Devices
Boston Scientific has recalled (Class 1) its Imager II 5F Angiographic Catheters because there is a potential for the catheter tip to become detached during a patient procedure or during procedure preparation. The device is used to provide a pathway to deliver contrast agents to blood vessels including carotid arteries.
Drugs
Commenting on a 3/9 FDA/Federal Trade Commission workshop on a competitive marketplace for biosimilars, Pfizer says it welcomes steps FDA has taken to address misinformation about the products. The steps include publishing a draft guidance providing that reference product promotional materials should avoid representing or suggesting that a
Devices
FDA has cleared a Nitiloop 510(k) for its NovaCross CTO Microcatheter. The device is intended to facilitate the intraluminal placement of conventional and steerable guidewires beyond stenotic lesions, including chronic total occlusions, prior to percutaneous transluminal coronary angioplasty or stent intervention, according to the company. It is also intended
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Global Treat Srl, Galati, Romania (3/31): FDA inspected the firm 9/2019 and cited significant GMPs for finished pharmaceuticals. For example, Global Treat failed to perform, for each
FDA Policy/General
Federal Register notice: FDA has corrected a 1/8 Federal Register notice that announced the withdrawal 23 ANDAs. Before FDA withdrew the approval of the ANDAs, Casi Pharmaceuticals informed the agency that it did not want its applications withdrawn. Because Casi timely requested that approval of these ANDAs not be
FDA Policy/General
Federal Register notice: FDA has released a report providing options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs for human drug and biosimilar biologic reviews under the agency’s user fee program. The agency is seeking comments on the report, and after
FDA Policy/General
Federal Register notice: Due to the current Covid-19 health emergency, FDA has postponed a 4/21-planned Pulmonary-Allergy Drugs Advisory Committee meeting. Panel members were scheduled to discuss a GlaxoSmithKline supplemental NDA for Trelegy Ellipta, a fixed-dose combination (fluticasone furoate, umeclidinium, and vilanterol) inhalation for reducing all-
Drugs
A 9/9-9/13/19 FDA inspection at Global Treat Srl, Galati, Romania, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/31 Warning Letter says specific violations were: * failing to perform, for each batch of a drug product, appropriate laboratory determination of
Drugs
Kaiser Permanente says an FDA question-and-answer draft guidance on promotional labeling and advertising considerations for prescription biological reference and biosimilar products “will help abate misinformation campaigns that unfairly reduce patient and prescriber confidence in biosimilars.” The health system’s comment letter also encourages the agency to build on
Devices
FDA says that for the duration of the coronavirus public health emergency in the U.S. it will not object to limited modifications to the indications, functionality, hardware, and/or software of 510(k)-cleared devices for remote assessment and monitoring of ophthalmic parameters. An immediately-in-effect guidance says
Drugs
FDA has approved a Bristol Myers Squibb and Acceleron Pharma BLA for Reblozyl (luspatercept-aamt), an erythroid maturation agent for treating anemia after failing an erythropoiesis stimulating agent and requiring two or more red blood cell units over eight weeks in adult patients with very low- to intermediate-risk myelodysplastic
Drugs
As president Trump and his allies daily tout the off-label use of the malaria drug hydroxychloroquine for treating caronavirus patients, former FDA commissioner Scott Gottlieb says that if the drug is working, its “effect is probably subtle enough that only rigorous and large scale trials will tease it out.
Drugs
A new Government Accountability Act report examined 637 NDAs submitted between 2014 to 2018 and found that while the agency met its review goals, differences in review times among the review divisions were “largely driven by the characteristics of the applications being reviewed.” The government watchdog agency was tasked with
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery” (OMB Control Number 0910-0697). The collection allows customer and stakeholder feedback on their perceptions, experiences and expectations. It is intended to provide an early
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice” (OMB Control Number 0910–0543). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has rescheduled for 5/5 a public meeting entitled “Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; Request for Comments.” The meeting now will take place by Webcast only. To view the notice, click here.
Devices
As resources are prioritized to responding to coronavirus-related activities, CDRH says it has further extended its reliance on teleconferences in lieu of in-person meetings with industry scheduled through 5/31.“ We are converting each meeting to a teleconference to be held at the same date and time,” a
Devices
FDA has posted a final guidance entitled “Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency.” The policy applies to large volume parenteral infusion pumps, syringe infusion pumps, patient-controlled analgesia infusion pumps, and ambulatory infusion pump devices, and their accessories, in
Drugs
FDA has released a final guidance on “Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744Kof the FD&C Act.” The document is intended for entities that compound human drugs and elect to register as outsourcing facilities under section 503B of the Federal Food, Drug, and
FDA Policy/General
Absolute Antibody Ltd. and Kerafast Inc. say they have agreed to a merger to improve the selection of research tools available to the scientific community. Absolute Antibody specializes in the sequencing, engineering and recombinant production of antibodies. It says its catalog offers more than 3,400 recombinant antibodies in new
Drugs
DEVICES FDA has cleared a Neusoft Medical Systems 510(k) for its new 128-slice NeuViz Prime CT scanner. The device features “Spectral Imaging” capabilities to perform image acquisition and processing at multiple energy levels for computed tomography. Neusoft says the scanner also offers 0.259 second rotation speed for