Devices
CDRH Office of Device Evaluation director William Maisel says the agency is concerned by continued reports of misconnections with enteral devices. In a letter to enteral feeding tube manufacturers, healthcare professionals, and hospital purchasing departments and distributors, Maisel says FDA recommends that hospitals and clinicians use enteral devices with connectors
Devices
FDA has cleared an Iridex 510(k) for the TruFocus LIO Premiere laser accessory, a light combination and reflection viewing system used with the Iridex retina laser systems and is worn on the physician’s head. “The product combines a laser treatment beam from an Iridex laser source with the
Drugs
FDA has approved Teva’s Cassipa (buprenorphine and naloxone) sublingual film for maintenance treatment of opioid dependence. An agency statement says the approval provides a new 16 mg/4 mg dosage strength of buprenorphine and naloxone sublingual film. The drug was approved through the 505(b)(2) abbreviated approval pathway
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.” As a general matter, high-risk and innovative moderate-risk devices will “typically need clinical evidence to show reasonable
Devices
FDA has cleared an AMDT Holdings 510(k) for its SixFix deformity analysis and correction software and instrumentation. The device, indicated for use with the Smith & Nephew Taylor Spatial Frame, reduces the time and effort involved in manual input of measurements and their values as required by currently available
Drugs
Beaumont Bio Med has recalled its entire aqueous/alcohol-based product line due to possible microbial contamination. All products are manufactured by contract manufacturer King Bio. “The administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention, and could result
Drugs
FDA has issued a draft guidance, Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials, to advise firms that manufacture, market, or distribute dietary supplements of the agency’s intent to exercise enforcement discretion about the declaration of live microbial quantity in colony forming units (CFUs) in addition to
Drugs
A 7/11-7/22/16 FDA inspection at Advanced Pharma, Houston, TX, a drug outsourcing facility now owned by Avella Specialty Pharmacy, found that drugs that violate the Federal Food, Drug, and Cosmetic Act were produced in the facility. An 8/14 Notice of Violation lists these issues: * failing
Devices
Ohio State University assistant professor of physical medicine and rehabilitation Lynne Gauthier has petitioned FDA to expand 510(k) exemption status to all small and portable sensors that can be used for relaxation of muscular reeducation. The petition says that new sensors have recently become available that provide the same
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Nonallergic Rhinitis: Developing Drug Products for Treatment.” The document incorporates comments received on a 2/2016 draft guidance. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Allergic Rhinitis: Developing Drug Products for Treatment.” The document addresses trial designs, effectiveness, and safety for new products being developed for the treatment of seasonal allergic rhinitis and perennial allergic rhinitis. To view the notice, click here.
Drugs
CDER has published a Manual of Policies and Procedures. Good Review Practice: Refuse to File, outlining the policies, responsibilities, and procedures for the Office of New Drugs to follow to determine whether there is a basis to refuse to file (RTF) an NDA, sNDA, BLA, or sBLA submitted to CDER.
Devices
Intuitive Surgical has submitted a 510(k) for the company’s new flexible robotic-assisted, catheter-based platform, which is designed to navigate through very small lung airways to reach peripheral nodules for biopsies. The device is intended to address the majority of suspicious lesions found in the lung that
Drugs
FDA deputy commissioner for policy, planning, legislation, and analysis Anna Abram told the Association for Accessible Medicine’s GRx+Biosims 8/5 meeting that FDA is making significant progress in carrying out its Drug Competition Action Plan and Biosimilars Action Plan. She reviewed actions taken under each program and also
FDA Policy/General
Federal Register notice: FDA has extended the comment period on six draft guidance documents about developing human gene therapy products that appeared in the 7/12 Federal Register. Comments are now being accepted until 12/10. To view the notice, click here.
Devices
FDA has issued a draft guidance, Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions, describing the agency’s current approach to considering uncertainty in making benefit/risk determinations for some medical device applications. “FDA believes the approach described
Drugs
FDA has published guidances to assist sponsors in developing products to treat allergic and nonallergic rhinitis. Allergic Rhinitis: Developing Drug Products for Treatment addresses issues of trial design, effectiveness, and safety for new products being developed to treat seasonal allergic rhinitis and perennial allergic rhinitis. The document says its recommendations
Drugs
CDER has issued a Manual of Policies and Procedures for the site selection model (SSM) used by Center staff to prioritize manufacturing sites for routine CGMP surveillance inspections. The document says the Center implemented a risk-based approach to prioritizing human drug manufacturing sites for routine CGMP surveillance inspection in
Drugs
A new analysis commissioned by the Pharmaceutical Research and Manufacturers of America (PhRMA) shows that about one in five hospitals marks up medicine prices 700% or more. The analysis is presumably intended to deflect criticism of the pharmaceutical industry for unnecessarily raising drug prices and thus burdening U.S. health
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification” (OMB Control Number 0910-0806). The guidance is intended to aid trading partners in identifying a suspect product and terminating a notification
Drugs
The International Contrast Ultrasound Society (ICUS) is asking FDA to remove Boxed Warnings from ultrasound contrast agent (UCA) labels “in order to bring the labeling into line with the current body of scientific research, which now clearly demonstrates the favorable safety profile and clinical benefits of these radiation-free diagnostic
Devices
CDRH has released a draft guidance entitled “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.” The document describes FDA’s current approach to this topic. FDA says its approach is tailored to the type and intended use of