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
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Food Labeling; Notification Procedures for Statements on Dietary Supplements — 21 CFR 101.93,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. FDCA 403(r)(6) and its implementing
Drugs
FDA has told Tetraphase Pharmaceuticals that it will need positive data from an additional Phase 3 trial for its lead candidate, eravacycline, in order to support an NDA for the antibiotic. The drug has shown potent activity against drug-resistant bacteria, including multidrug-resistant pathogens, the company says. Based on
Drugs
In issuing a 5/12 drug safety communication on fluoroquinolones when they are used systemically, the agency also simultaneously denied a 2014 petition seeking to change the professional labeling for Johnson & Johnson’s Levaquin (levofloxacin) to warn about possible mitochondrial toxicity. The petition denial letter says that an agency
Devices
FDA has finalized a guidance on “Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act” that provides recommendations on the format, content, and review of postmarket surveillance plan submissions. Section 522 gives FDA the authority to order postmarket surveillance for any Class 2 or 3 device
FDA Policy/General
Federal Register Notice: The FDA commissioner renews that charter of the Pulmonary-Allergy Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/30/18. To view this notice, click here.
Devices
FDA has approved a NeoChord, Inc. IDE to begin a clinical study of its artificial chordae delivery system, DS1000, a trans-apical beating heart procedure for replacing ruptured or elongated chordae in patients with degenerative mitral valve regurgitation. The company says it is the first U.S. study of its
Drugs
FDA says that so far there is no indication that counterfeit drug product labeled as BiCNU (carmustine for injection) 100 mg has entered the legitimate U.S. drug supply chain, or that any U.S. patients have received any of the suspect product. Earlier this week, Heritage Pharmaceuticals said (see
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers. It provides recommendations to assist industry in designing studies to establish the analytical and clinical performance characteristics of infectious disease next
FDA Policy/General
Federal Register Notice: FDA is making available a guidance for industry entitled Frequently Asked Questions About Medical Foods; Second Edition. This guidance provides responses to additional questions on the definition and labeling of medical foods and updates some prior responses. To download this guidance, click here. To view this notice,
Drugs
FDA has granted fast-track designation to Edge Therapeutics for its EG-1962 for treating aneurysmal subarachnoid hemorrhage (aSAH). The company describes it as a novel polymeric nimodipine microparticle containing nimodipine suspended in a diluent of sodium hyaluronate that uses the company’s Precisa development platform and that is designed
FDA Policy/General
HHS general counsel Bill Schultz has announced his resignation from the department. Before joining HHS, he was a partner at Zuckerman Spaeder. Schultz has also previously served as Department of Justice deputy assistant attorney general, and FDA deputy commissioner for policy. Before joining FDA, he served as counsel to the
Drugs
FDA this week granted breakthrough therapy status to a Duke University-based company’s new therapy that cured recurrent brain gioblastoma in three patients and extended life for others in a clinical trial from 10 to 15 months, according to a CBS 60 Minutes report to be aired Sunday and
Devices
Reason TV, an online content provider using YouTube, has created a 10-minute documentary film “celebrating the courage” of Vascular Solutions and its CEO Howard Root in mounting a successful $25 million defense against government criminal charges of illegal off-label promotion of the company’s Vari-Lase Short Kit.
Drugs
Former FDA commissioner Margaret Hamburg and former NIH director Elias Zerhouni say that global drug regulatory harmonization is a public health imperative. Writing in an online Science Translational Medicine editorial, the two argue that “in this world of growing public health needs, limited resources, and incessant demand for more, faster,
Devices
AdvaMed senior executive vice president for technology and regulatory affairs Janet Trunzo says the Advancing Breakthrough Devices for Patients Act of 2016 “does nothing to lessen FDA’s current rigorous approval standards for breakthrough medical devices and diagnostics, but instead will improve access to potentially life-saving and life-enhancing
Devices
AdvaMed says that given the many substantive requirements in a new FDA draft guidance on characterization of ultrahigh molecular weight polyethylene used in orthopedic devices, as well as in the existing draft guidance that the new one replaces, it will be important for the agency to finalize the latest draft
Drugs
FDA has cleared an Xtant Medical Holdings 510(k) for a posterior cervical screw indication on the Certex Spinal Fixation System, which the company says can be linked to the Fortex Pedicle Screw System and the Xpress Minimally Invasive Pedicle Screw System with rod-to-rod connectors and transition rods.
Devices
FDA has issued a draft guidance on “Infectious Disease Next Generation Sequencing Based Diagnostic Devices:Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers,” which provides recommendations for studies to establish the analytical and clinical performance characteristics of such devices. “Each unique specimen type may require a different nucleic