Drugs
Deputy attorney general Sally Yates, who drafted the Individual Accountability Policy that has become known as the “Yates Memo,” says that implementation of the policy has already had the desired effect of changing corporate behavior. Speaking to the 5/10 New York City Bar Association White Collar Crime conference, Yates
Drugs
The study involved 365 patients, who were randomized 1:1 to treatment with up to six cycles of of atumumab in combination with fludarabine and cyclophosphamide or up to six cycles with fludarabine and cyclophosphamide alone. The study met the primary endpoint with a median progression free survival in patients
Drugs
FDA has granted accelerated approval to Bristol-Myers Squibb for its NDA for Opdivo (nivolumab) and its use in treating patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin (Adcetris). The approval was granted three and a
Devices
Zimmer Biomet, Stryker, and Johnson & Johnson all say they agree with comments submitted by AdvaMed on an FDA draft guidance on characterization of ultrahigh molecular weight polyethylene (UHMWPE) used in orthopedic devices. Stryker says that as in the AdvaMed comments, it also recommends that the agency finalize the guidance
Devices
FDA has cleared a Millennium Dental Technologies 510(k) for periodontal regeneration (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface using the company’s LANAP protocol. Using a PerioLase MVP-7 laser, doctors can “stimulate and activate oral stem cells, in particular fibroblasts,
FDA Policy/General
FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Eclipse Aesthetics, LLC. Farmers Branch, TX (3/28). Inspected 8/5-13/15. Adulterated, misbranded: The firm does not have an approved PMA or IDE application. Also, the firm did
Drugs
An Alabama federal court has dismissed a case charging that Wyeth failed to update labeling for its generic metoclopramide. Writing in an online blog post, attorney James Beck says that the plaintiff alleged that for a period of several months in 2004-05, the company did not include the latest
Devices
Opposition to FDA’s medical device unique device identifier (UDI) program appears to be waning at the Center for Medicare and Medicaid Services, according to recent remarks made by CMS acting administrator Andy Slavitt. CMS had opposed adding the UDI to claims forms due to technological challenges associated with the
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act. It is intended to assist manufacturers of devices subject to Section 522 postmarket surveillance orders by providing an overview of the Federal Food, Drug, and Cosmetic Act,
Devices
FDA has cleared a Bone Index 510(k) for the Bindex point-of-care instrument, which is intended to help in osteoporosis diagnosis. The device measures the cortical bone thickness of the tibia and its algorithm calculates a density index, a parameter which estimates bone mineral density at the hip
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a guidance for industry entitled Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification. It is intended to assist submitters of a biomarker for qualification that conduct nonclinical biomarker qualification studies in which histopathology is used as a reference
FDA Policy/General
FDA has posted a draft guidance on the “Use of Electronic Health Record (EHR) Data in Clinical Investigations.” The document provides recommendations on deciding whether and how to use EHRs as a source of data in clinical investigations, and their interoperability with electronic systems supporting clinical investigations. It also discusses
FDA Policy/General
FDA continues to be concerned with the same top inspectional findings repeating every year during drug and device inspections, CDER Office of Product Quality acting branch chief Andrea Chamblee told the Food and Drug Law Institute’s annual meeting in Washington, DC 5/12. For example, the top inspectional findings
Devices
FDA has cleared a First Ray 510(k) for its CortiClamp System for small bone fixation. The device uses a second screw head that is attached to the distal end of the screw, providing screw heads on both ends of the screw shaft that create a bi-cortical clamping force,
Devices
Medtronic has recalled its battery pack used with the Capnostream 20 and Capnostream 20p Patient Monitors due to the potential for thermal runaway that presents a fire risk to the monitor. The battery pack powers the monitor when AC power is not available or when monitoring is required during intra-
Drugs
The FDA-endorsed Clinical Trials Transformation Initiative has released new recommendations on best practices for using Data Monitoring Committees (DMCs) to ensure the validity and integrity of a clinical trial when there is a need to periodically review accumulating safety and efficacy data and advise on whether to continue, modify,
Drugs
FDA has approved an Eisai NDA for Lenvima (lenvatinib) capsules for combination use with everolimus for treating advanced renal cell carcinoma following one prior anti-angiogenic therapy. Lenvatinib was first approved in 2015 for treating locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. The expanded approval was
FDA Policy/General
DEVICES Comments Extended on GMPs for Hearing Aids Federal Register Notice: FDA is extending the comment period to 6/30 for the document entitled “Streamlining Regulations for Good Manufacturing Practices for Hearing Aids; Public Workshop,” that appeared in the 1/7 Federal Register. FDA requested comments on the appropriate level
Drugs
DEVICES Bone Index Ltd. has received 510(k) clearance from FDA for the Bindex point-of-care instrument to help in osteoporosis diagnosis. According to the company, Bindex measures the cortical bone thickness of the tibia and the algorithm calculates the Density Index, a parameter which estimates bone mineral density
Drugs
FDA has granted Akari Therapeutics an orphan drug designation for coversin, a recombinant protein inhibitor of complement factor 5 for treating Guillain Barr Syndrome. The company says the second-generation complement inhibitor is intended to act on complement component-C5, preventing release of C5a and formation of C5b-9 (also
FDA Policy/General
FDA has posted a guidance on “Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification.” The FDA Critical Path Initiative identified the discovery, characterization, qualification, and use of biomarkers as important for improving medical product development efficiency and success rates, the document notes. “The type of