Drugs
FDA has expanded the use of Bayer’s Stivarga (regorafinib) to include treating patients with hepatocellular carcinoma (liver cancer) who have been previously treated with the drug sorafenib. This is the first agency-approved treatment for a liver cancer in almost a decade, an FDA release says. Stivarga is a
Drugs
In more than an hour of oral arguments 4/26, representatives of Amgen and Sandoz highlighted their differing interpretations of the requirements in the Biologics Price Competition and Innovation Act before the Supreme Court. Media accounts indicate that the principal issues argued included whether FDA can approve a biosimilar before
Drugs
The Corporate Whistleblower Center, a self-described advocate for whistleblowers in the U.S., is asking drug company employees to report to it instances of unsanitary conditions on a drug manufacturing line. “The reason this is such a big deal,” the center says in a news statement, “is because drugs
Devices
The House Energy and Commerce Committee Subcommittee on Health will hold a 5/2 hearing on “Examining Improvements to the Regulation of Medical Technologies.” A subcommittee news release says that earlier this month bipartisan leaders of the full committee and the Senate HELP committee released a discussion draft of the
FDA Policy/General
The Senate Health, Education, Labor & Pensions Committee has voted 14 to 9 to report out and send the nomination of Scott Gottlieb as the next FDA commissioner to a floor vote. Gottlieb previously served as deputy FDA commissioner during the George W. Bush administration. Two Democrats joined Republicans in
Drugs
FDA has approved label changes on the use of general anesthetic and sedation medicines in children younger than three years. These changes include: * A new Warning stating that exposure to these medicines for long periods or over multiple surgeries or procedures may negatively affect brain development. * Addition of information about
Drugs
Attorney Michelle Yeary (Reed Smith) says a Louisiana federal judge erred in determining that Xarelto (rivoroxaban) multi-district litigation claiming that the drug was unreasonably dangerous due to a design defect was not preempted under the Supreme Court’s Bartlett decision. Writing in an online blog post, Yeary says that
FDA Policy/General
Federal Register notice: FDA has announced a 7/10 public workshop entitled “Sentinel Training at FDA” that is intended to provide training on the kinds of questions that can be asked using health care claims data under the Sentinel System. To view the notice, click here.
Drugs
FDA has cleared a Reapplix 510(k) for its 3C Patch System including the 3C Patch Centrifuge. The device is intended to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma gel from a small sample of a patient’s own peripheral blood.
FDA Policy/General
Federal Register notice: FDA has issued a priority review voucher to Marathon Pharmaceuticals for its recently approved Emflaza (deflazacort) tablets and oral suspension for treating patients age five and older with Duchenne muscular dystrophy (DMD). An agency news release says that Emflaza is a corticosteroid that works by decreasing inflammation
Drugs
Six CDER staffers say the Center is tracking the use of nanotechnology in drug products by building and interrogating a technical profile of products containing nanomaterials submitted to CDER. Writing online in Nature Nanotechnology (subscription or purchase required), the six say that data from more than 350 products show an
FDA Policy/General
Federal Register notice: FDA is seeking comments on a report submitted by Duke Clinical Research Institute evaluating pediatric studies of ampicillin that were conducted under a written request for pediatric data to determine the safe use as a first line antibiotic therapy for certain infections. To view the notice, click
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new information collection on “Certification of Identity for Freedom of Information Act (FOIA) and Privacy Act Requests — OMB Control Number 0910.” The new form is intended to provide the agency with data necessary to identify an individual requesting a particular record
FDA Policy/General
The Senate Health, Education, Labor & Pensions (HELP) Committee has postponed a vote (see earlier story) until 4/27 on Scott Gottlieb to be the next FDA commissioner. The previous voted was scheduled for 4/26, but committee chairman Lamar Alexander (R-TN) postponed it due to a scheduling issue
Drugs
Reps. Ann Kuster (D-NH) and Mimi Walters (R-CA) have introduced HR 2144 that would require FDA to implement an efficient, streamlined process for classifying medical device accessories. In announcing support for the measure, the Advanced Medical Technology Association (AdvaMed) said it would “establish a new procedural mechanism for
Drugs
FDA has granted in part and denied in part an Adapt Pharma Operations 11/23/16 petition asking that the agency not approve any ANDA referencing Adapt’s Narcan (naloxone hydrochloride) nasal spray that does not provide specific pharmacokinetic, device, stability, and chemistry, manufacturing, and controls data. FDA’s response
FDA Policy/General
Federal Register notice: FDA, the National Science Foundation and Department of Homeland Security, Science and Technology have announced a public workshop (5/18-19) entitled “Cybersecurity of Medical Devices: A Regulatory Science Gap Analysis.” The workshop is intended to discuss the current state of regulatory science in the field of
Devices
FDA has cleared a Bausch + Lomb 510(k) for Vitesse, a hypersonic device for vitreous removal. The device features a single-needle design and a continuously open-port system. It will exclusively operate on the company’s new Stellaris Elite Vision Enhancement System, the company’s next generation phacoemulsification cataract
Drugs
Matrix Global Advisors says there are ways the next FDA commissioner can address drug prices by promoting competition. In a white paper, the consulting group says the “widespread public frustration over drug prices is an indication that competition must begin receiving attention at FDA comparable to what has been focused
Devices
FDA has cleared a Samsung 510(k) for the GC70 Digital Radiography (DR) system. The device “creates high-quality images with cutting-edge digital enhancements such as the S-Vue imaging engine, which provides high resolution images through adaptive filtering, the company says. It features S-Align to help provide
Drugs
FDA has approved Inspirion Delivery Sciences’ RoxyBond (oxycodone hydrochloride) tablets, indicated for managing pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The company describes RoxyBond as the first immediate-release opioid analgesic approved with labeling describing its abuse-deterrent properties, consistent with the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act — OMB Control Number 0910–0679.” The guidance describes the agency’s interpretation