Devices
FDA has classified as Class 1 a GE Healthcare recall of its CareScape R860 Inspiratory Safety Guard, a breathing accessory designed for use with the Carescape R860 Ventilator. The ventilator provides mechanical ventilation and breathing support to infants, children, and adult patients, and the safety guard is designed for use
Drugs
FDA has cleared a DBM Corp. 510(k) for its Miracu PDO Suture Threads and its use on soft tissue approximation where absorbable sutures are appropriate. The device’s cannula (needle) has a surface coating smoother than that of traditional catgut sutures, coupled with ultra-thin walls for maximum pain
Drugs
A 7/23-8/3 FDA inspection at Zhejiang Huahai Pharmaceutical Co., Taizhou Zhejiang, China, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). An 11/29 Warning Letter said specific deviations were: * failure of the quality unit to ensure that quality-related complaints are
Devices
Olympus Medical Systems and a former senior executive in Japan pleaded guilty 12/10 in Newark, NJ federal court for failing to file required adverse event reports involving its duodenoscopes and associated infections, and continuing to sell the devices knowing the likely failures, according to a Justice Department release. U.
Drugs
FDA says Skylark CMC Pvt. Ltd., Gujarat, India, refused to cooperate with a FDA inspection beginning 6/25. A 12/3 Warning Letter says the company: * barred access to manufacturing areas; and * refused to provide copies of records sought by the inspector. The letter says FDA conducted an unannounced inspection
FDA Policy/General
Federal Register notice: FDA has announced a 5/21 public meeting entitled “FDA’s Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock.” The meeting is intended to provide interested parties with an opportunity to present to FDA their perspectives concerning access to office
FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance entitled “Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” Based on feedback from stakeholders and comments received on the initial draft guidance, the document is being revised
Drugs
FDA commissioner Scott Gottlieb says the agency is taking steps to advance the framework outlined in the July Biosimilars Action Plan by issuing four new guidances, including one that takes on companies that are “using, and sometimes abusing, limited distribution systems, sometimes in connection with Risk Evaluation and Mitigation Strategy
Drugs
Former FDA associate commissioner Peter Lurie, now president of the Center for Science in the Public Interest, and New York University journalism professor Charles Seife are suing HHS, FDA, and the National Institutes of Health in an effort to overturn their rule purporting to relieve medical researchers of their legal
Drugs
FDA has issued a draft guidance, Biomarker Qualification, Evidentiary Framework, with recommendations on general considerations to address when developing a biomarker for qualification under the 21st Century Cures Act, enacted 12/13/16. The document discusses the evidentiary framework that should be used to support biomarker qualification. FDA says the
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) to describe how the responsibility for the integrated quality assessment of products containing drug substances composed of amino acid polymers will be divided among the Office of New Drug Products, Office of Lifecycle Drug Products, Office of Process and Facilities,
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Skylark CMC Pvt. Ltd. Gujarat, India (12/3): FDA attempted to inspect the drug manufacturing facility in June but employees refused access to the manufacturing area. The firm also
Drugs
FDA has released the FDA-483 issued following a 10/22-10/26 inspection at Dishman Carbogen Amcis, a Gujarat, India, active pharmaceutical ingredient manufacturer. The two inspection observations in the document were: * blending of in-specification with out-of-specification intermediate batches is performed; and * laboratory investigations for out-
Devices
More than 140 industry and advocacy groups are urging Congress to permanently repeal the medical device tax before the end of this year. The tax is set to be reinstated in 2019. “Full repeal of the device tax would mean that the medical technology industry can continue innovating new approaches
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA draft guidance on chemistry, manufacturing, and control (CMC) information for human gene therapy INDs is a positive step toward providing sponsors with more guidance and clarity, but “does not adequately adopt and identify risk-based and phase-appropriate recommendations that
Drugs
FDA has released a revised draft guidance entitled “Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act” that provides recommendations to reduce risks of contaminated or otherwise substandard products produced by outsourcing facilities. “Maintaining the necessary standards to protect
FDA Policy/General
Federal Register notice: FDA has announced a 2/12 Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee meeting. Panel members are expected to discuss and make recommendations about the safety and effectiveness of surgical mesh placed transvaginally in the anterior vaginal compartment to treat pelvic organ prolapse.
FDA Policy/General
Federal Register notice. FDA has issued an order debarring physician Su-Chiao Kuo for three years from providing services in any capacity to a person that has an approved or pending drug product application. The action is based on a finding that Kuo was convicted of a misdemeanor for causing
FDA Policy/General
Federal Register notice: FDA has issued an order debarring David J. Fishman for three years from providing services in any capacity to a person that has an approved or pending drug product application. The order is based on a finding that Fishman was convicted of a misdemeanor for causing the
Devices
AdvaMed has identified guidance documents that FDA should prioritize in its fiscal year 2019 plan on proposed documents to be developed. In comments to the agency, AdvaMed recommends that FDA finalize several of the draft guidances that it has issued within the last year. For example, the group says the
Drugs
Pfizer’s Hospira drug unit appears to be getting deeper into FDA hot water involving intractable GMP issues at the firm’s McPherson, KS sterile drug manufacturing site. The latest indication is a just-released Form FDA-483 that lists numerous repeat observations cited after an August follow-up inspection
Drugs
Pfenex has submitted an NDA for PF708, indicated for treating osteoporosis. The 505(b)(2) NDA submission, which references Eli Lilly’s Forteo (teriparatide), is based on positive data from the PF708-301 Phase 3 clinical study that showed comparable overall profiles between PF708 and Forteo after 24 weeks of