Devices
FDA has cleared a Becton Dickinson 510(k) for the BD Vacutainer Barricor plasma blood collection tube, a “next generation” blood collection and separation technology designed, the company says, to improve sample quality and help clinicians receive test results faster. The single-use, plastic evacuated tube uses a novel mechanical
FDA Policy/General
The Government Accountability Office (GAO) says its review of security controls over seven key FDA information systems found “a significant number of security control weaknesses [that] jeopardize the confidentiality, integrity, and availability of its information and systems.” The GAO report says that FDA did not fully or consistently implement access
FDA Policy/General
FDA should ban the use of triclosan in toothpaste, as it did in hand soaps earlier this month, according to the Cornucopia Institute. In a 9/29 letter to FDA, the group says FDA should take this action because triclosan is an endocrine disruptor. “Specifically, it disrupts thyroid, testosterone, and
Devices
Two CDRH officials say that under a new Use of Symbols in Labeling final rule, medical device manufacturers have three options. Senior policy analyst Antoinette Hazlett and health standards program director Scott Colburn say in an FDA Voice blog post that companies can (1) choose not to use symbols, (2)
Drugs
Pharmaceutical Research and Manufacturers of America says in a comment letter on an FDA draft guidance on quality metrics technical conformance that it commends the agency’s innovative vision to harness its new authorities under the FDA Safety and Innovation Act to use quality metrics reporting in risk-based scheduling
Devices
Duke University’s National Evaluation System for health Technology (NEST) planning board has outlined key priorities for its new coordinating center as it works to implement a national system for medical device evaluation. The 25-member board includes patients, clinicians, the medical device industry, payers, and regulatory experts, as well
Drugs
An analysis published in the BMJ shows that of 55 unique FDA hematology-oncology medical reviewers from 2001 to 2010, 26 left agency employment and 15 of them (57.7%) later worked or consulted for the biopharmaceutical industry. The study authors from Oregon Science and Health University say they are
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for a Medicines Company NDA for Ionsys (fentanyl iontophoretic transdermal system) that applies to a patent extension for the product. The agency determined that the applicable regulatory review period for the drug is 4,835 days. To view this notice,
Drugs
Three members of the Senate Judiciary Committee — Chuck Grassley (R-IA), Richard Blumenthal (D-CT), and Amy Klobuchar (D-MN) — are asking the Department of Justice to investigate whether Mylan Pharmaceuticals violated the law when it apparently misclassified its EpiPen for the Medicaid drug product rebate program. In a 9/
Drugs
China’s State Food and Drug Administration (SFDA) says that more than 80% of clinical data from clinical trials in that country are “fabricated.” Radio Free Asia (RFA) reports that Chinese state media say that a one-year SFDA study found “breach of duty by supervision departments and malpractice by
Drugs
FDA and Athersys have reached agreement on a special protocol assessment for the design and planned analysis of a Phase 3 clinical trial involving the company’s MultiStem cell therapy product for treating ischemic stroke. The agreement applies to the protocol design, clinical endpoints, planned conduct and statistical analyses, which
Devices
FDA says it has updated the Expedited Access Pathway (EAP) Program Web site with two Data Development Plan examples that are a resource for sponsors. The agency released 4/2015 a guidance that introduced that new voluntary program to promote development of innovative products to address unmet medical needs for
Biologics
FDA has accepted for review an Amgen and UCB BLA for romosozumab, an investigational monoclonal antibody for treating osteoporosis in postmenopausal women at increased risk of fracture. The companies say romosozumab works by binding and inhibiting the activity of the protein sclerostin, a protein naturally occurring in the bone, thereby
Drugs
CDER says it is conducting a nationwide search for the permanent position of Office of Translational Sciences (OTS) deputy director for science. Current deputy Jan Johannessen is retiring soon. The deputy handles OTS science matters and administration of science and research programs, as well as influencing the formulation of basic
Devices
FDA has approved Medtronic’s MiniMed 670G hybrid closed looped system, the first agency-approved device that is intended to automatically monitor glucose and provide appropriate basal insulin doses in people 14 years of age and older with Type 1 diabetes. “The MiniMed 670G hybrid closed looped system, often referred
Devices
FDA has approved an Abbott PMA for the FreeStyle Libre Pro system, a continuous glucose monitoring system for healthcare professionals to use with their diabetic patients. The device is intended to provide healthcare professionals with a visual snapshot of glucose data, known as the Ambulatory Glucose Profile (AGP), “giving a
Biologics
CDRH Division of Biostatistics deputy director Gerry Gray defined adaptive trial designs in a 9/22 webinar as “clinical studies that include some prospectively planned opportunity or set of opportunities to change the study design based on data accumulated during the course of the study without undermining the integrity and
Drugs
DePuy Synthes has recalled its Small Battery Drive and Small Battery Drive II Adaptor and Light Adaptor, which are used in the company’s surgical tool systems, due to a potential explosion risk. An FDA recall notice says the battery drives have the potential to produce “extreme internal pressure, which
Devices
An Ohio federal court has dismissed five cases brought against Medtronic alleging state-law liability over off-label use of its Infuse product used to stimulate bone growth in spinal fusion surgeries. The plaintiffs’ complaints involved fraudulent concealment and misrepresentation, failure to warn, design defect, misrepresentation, negligence, and breach of
Devices
FDA has cleared a Medtronic 510(k) for the StealthStation cranial software as an aid for deep brain stimulation (DBS) lead placement. The software is fully integrated with the company’s latest O-arm Imaging System that helps clinicians with the planning and placement of DBS leads. With Medtronic'
Devices
FDA has cleared a Quidel 510(k) to market its Solana Influenza A+B assay for detecting nucleic acids isolated from nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection to aid in diagnosing Influenza A and B infections. The assay is intended for use only
Drugs
FDA has placed a clinical hold on a CEL-SCI Corp. Multikine (leukocyte interleukin injection) Phase 3 clinical trial in advanced primary head and neck cancer. “Pursuant to this communication from FDA, patients currently receiving study treatments can continue to receive treatment, and patients already enrolled in the study will