Devices
FDA says currently available objective evidence is not sufficient to conclude whether there is a widespread public health concern related to servicing of medical devices that would justify imposing additional or different burdensome regulatory requirements at this time. That position is stated in a 5/2018 agency report on the
Devices
Serious security flaws were found in Philips, GE, and Silex medical devices that, if exploited, could allow unauthorized access and let a hacker obtain elevated privileges, according to two HHS cybersecurity alerts. Healthcare IT News outlines the issues raised in the HHS reports and company actions to resolve them.
Drugs
The Supreme Court of Appeals of West Virginia says there is no cause of action in the state for failure to warn and negligent misrepresentation against a brand-name drug manufacturer when the drug taken by a plaintiff was produced by a generic drug company. The court issued its 5/
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Product Quest MFG, Daytona Beach, FL (4/16): FDA inspected the firm 10/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to maintain
FDA Policy/General
Federal Register notice: FDA has made available a draft entitled “Pediatric HIV Infection: Drug Development for Treatment.” The document provides general recommendations on developing such drug products, including when sponsors should initiate pediatric formulation development and begin pediatric studies to evaluate antiretroviral drug products for treating HIV infection. To view
FDA Policy/General
Federal Register notice: FDA has announced a partial withdrawal of a proposed rule published in the 8/21/2003 Federal Register that would have amended the agency’s tentative final monograph (TFM) for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic drug products to include ibuprofen as generally recognized
Drugs
FDA has cleared a Baxter International 510(k) for the Spectrum IQ Infusion System with Dose IQ Safety Software. The device is designed for bi-directional electronic medical records integration with new features to help ensure the correct medications and fluids are delivered to each patient. Baxter says it provides
Drugs
FDA has approved a UCB supplemental NDA for Briviact (brivaracetam) CV oral formulations indicated as monotherapy and adjunctive therapy in treating partial onset (focal) seizures in patients age four years and older. The expanded indication is based on extrapolation of efficacy data from adults to children, and is supported by
Devices
FDA has granted Immunicom a breakthrough device designation for its Immunopheresis therapy, which is based on a proprietary technology that selectively removes immune inhibitors from patients’ bloodstreams and thus enables their natural immune system to more-effectively attack cancer tumors. “By removing immune system inhibitors from the blood without introducing
FDA Policy/General
“The secretary of HHS has a shocking amount of power by the stroke of a pen, and we intend to exercise it,” HHS secretary Alex Azar told PBS News Hour 5/14, addressing the cost of prescription drugs paid by Medicare for senior citizens − an issue FDA commissioner Scott Gottlieb
Drugs
FDA has released a 5/15 proposed rule that, once finalized, would bring more transparency to the combination product regulatory process. The proposal is intended to streamline and clarify the appeals process for manufacturers, and align the regulations with more recent legislative and regulatory measures. “These regulations address the process
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval a new proposed information collection entitled “DSCSA Pilot Project Program,” under which the agency would establish the pilot as mandated by the Drug Supply Chain Security Act. It is intended to assist FDA in developing an interoperable, electronic system to identify
Drugs
Rep. Tulsi Gabbard (D-HI) and senator Bernie Sanders (I-VT) have introduced legislation to hold pharmaceutical companies accountable for profiting from America’s opioid epidemic. The Opioid Crisis Accountability Act of 2018 would fine drug companies for false marketing and distribution of opioids, and create criminal liability for top
Drugs
FDA has approved a subcutaneous formulation of Genentech’s Actemra (tocilizumab) for treating active polyarticular juvenile idiopathic arthritis in patients two years of age and older. FDA in 2013 approved an intravenous formulation of Actemra for patients two years of age and older for the same indication. Actemra can be
FDA Policy/General
FDA Panel To Review Cordis PMA Adverse Events Federal Register notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee reviews a Cordis PMA for the Incraft AAA Stent Graft System. 05/11/2018 Guide on Outsourcing Facility Definition Federal Register notice: FDA makes available a guidance
FDA Policy/General
Federal Register notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee is scheduled to meet 6/12 to review a Cordis PMA for the Incraft AAA Stent Graft System, which is intended for the endovascular treatment of infra-renal abdominal aortic aneurysms in patients with appropriate
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” Section 503B defines an outsourcing facility, in part, as “a facility at one geographic location or address.” FDA has received questions from outsourcing facilities and other stakeholders
Drugs
President Trump’s just-released blueprint for lowering prescription drug prices orders FDA to require drug companies advertising their drugs to include pricing information in the advertisements. HHS secretary Alex Azar, who joined the president in a 5/11 Rose Garden announcement, had this to say: “Think about all the
Drugs
FDA has expanded the approval of Novartis’ Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. Gilenya was first approved by the FDA in 2010 to treat adults with relapsing MS. Approval was based on clinical trial data from 214 patients aged
Devices
Vyaire Medical has recalled its AirLife resuscitation devices and Broselow convenience kits due to risk of a malfunction caused by an error in the products’ design. The manual resuscitation devices are used together as one pair to provide constant ventilation to adults and children who are not breathing or cannot
Devices
A group of patient and industry organizations has written Congressional leaders urging them to enact legislation to “modernize the statutory oversight of clinical laboratory diagnostics, including laboratory developed tests (LDTs) and in vitro diagnostics (IVDs).” The 5/9 letter noted that FDA is currently reviewing an amended discussion draft of
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Request for Samples and Protocols” (OMB Control Number 0910–0206). FDA’s regulations give it authority to at any time require manufacturers of licensed biological products to submit samples of any lot along with the protocols showing