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Federal Register Notice: FDA is making available a draft guidance entitled Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and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
Drugs
FDA says that the serious side effects associated with fluoroquinolone antibiotics generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. An agency drug safety communication says that an FDA safety review found that when fluoroquinolones are used systemically, they are
Drugs
Aegerion Pharmaceuticals has reached preliminary agreements with the Department of Justice and the Securities and Exchange Commission involving a settlement of ongoing investigations by the feds into the company’s sales activities and disclosures related to Juxtapid (lomitapide). Under the agreement, the company will pay both agencies over five years
Drugs
FDA has granted AstraZeneca an orphan drug designation for the investigational MEK 1/2 inhibitor, selumetinib, indicated for adjuvant treatment of patients with Stage III or IV differentiated thyroid cancer. The condition is diagnosed in about 60,000 people in the U.S. each year, the company says. Some patients
Devices
FDA has cleared an EndoGastric Solutions 510(k) for the EsophyX Z device for treating gastroesophageal reflux disease using transoral incisionless fundoplication. “Designed for compatibility with the company’s existing 7.5 mm SerosaFuse Implantable Fastener cartridges, the device allows physicians to reconstruct the gastroesophageal valve and then secure tissue