Drugs
FDA has posted a guidance on “Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders.” The document provides recommendations for establishing clinical effectiveness for such drugs that do not cause structural disorders of the hypothalamus or pituitary gland. The drugs should both increase serum testosterone
Drugs
FDA has approved an Amgen BLA for Aimovig (erenumab), a once-monthly self-injection for preventing migraines in adults. Aimovig is the first monoclonal antibody targeting the calcitonin gene-related peptide receptor approved for migraines, an agency release says. Approval is based on data from three clinical trials. Overall, patients
Drugs
FDA has published a draft guidance on “Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease.” The document provides recommendations for developing such drugs for treating patients who have undergone solid organ or hematopoietic stem cell transplantation. It addresses FDA’s current thinking on the overall development program and
Devices
Medtronic has recalled its MindFrame Capture LP revascularization device due to wire material that may break or separate during use. The device is intended to restore blood flow or remove blood clots within a blood vessel in the brain during an acute ischemic stroke in patients who are ineligible for
Drugs
FDA has issued a safety alert about decreased survival associated with the use of Merck’s Keytruda (pembrolizumab) and Genentech’s Tecentriq (atezolizumab) as single therapy (monotherapy) in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the
FDA Policy/General
While the Trump Administration has its sights on slashing program areas at various federal agencies, FDA continues to get strong support on Capitol Hill for increased funding for new and existing program areas. On 5/16, a House Appropriations Committee mark-up for FDA’s fiscal year 2019 funding increased
FDA Policy/General
Federal Register final rule: FDA has classified blood establishment computer software and accessories (regulated under product code MMH) into Class 2 (special controls). The agency also provided notice that it does not intend to exempt BECS and BECS accessories from premarket notification requirements. To view the notice, click here.
Drugs
FDA has issued a safety alert about serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir (Viiv Healthcare’s Tivicay) used to treat human immunodeficiency virus. “Preliminary results from an ongoing observational study in
FDA Policy/General
Federal Register notice: FDA has announced a 6/14 Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee meeting to review a PneumRx PMA for the PneumRx Elevair Endobronchial Coil System. The agency described the device as a first of a kind implantable lung reduction coil for
Drugs
FDA and HHS’ Office for Human Research Protections have issued a joint guidance on “Institutional Review Board (IRB) Written Procedures; Guidance for Institutions and IRBs.” The document is intended to clarify requirements, reaffirm important human subject protections, and provide consistent recommendations for institutions and IRBs reviewing and overseeing research involving
Drugs
Three Alston Bird patent lawyers say a Federal Circuit Court of Appeals decision in Lilly v. Actavis Elizabeth conflicts with Supreme Court precedent and should be overturned. Writing in the New York Law Journal, the attorneys say the appeals court held that substantial non-infringing off-label uses of an
Drugs
FDA has released the names of 52 branded drug products whose manufacturers “have potentially been blocking access to the samples of their branded products” needed by generic drug companies to be able to develop and test their products. In a statement, FDA commissioner Scott Gottlieb said the agency hopes “that
Drugs
Vermont has become the first state to approve legislation permitting a U.S. drug wholesaler to import drugs from a Canadian wholesaler. The law still has to be certified by HHS. The Trump administration has opposed such drug importation. The Hill reports that HHS secretary Alex Azar called the idea
Drugs
FDA reportedly has backed away from awarding a sole source contract to the Duke-Margolis Center for Health Policy headed by former agency commissioner Mark McClellan, for whom now commissioner Scott Gottlieb used to work. Endpoint News says an initial request for proposal said the effort was to “provide supporting
Drugs
FDA has approved an Amneal Pharmaceuticals ANDA for a generic version of Daiichi Sankyo’s Welchol (colesevelam HCI) tablets, 625 mg. The product is approved along with diet and exercise for lowering LDL or “bad” cholesterol. It can be taken alone or with other statin cholesterol-lowering drugs. Welchol had
Devices
Federal Register notice: FDA has published a final order to exempt certain surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA is limiting the exemption to single-use, disposable respiratory protective devices used in a healthcare setting and worn by healthcare personnel during procedures to protect both
Drugs
Some 21 health experts are offering what they describe as a comprehensive proposal to ensure universal access to safe, innovative, and affordable medicines, according to a statement from Public Citizen. The plan, published in the British Medical Journal, identifies seven critical areas of reform, with short- and long-term solutions
Devices
FDA has cleared an Additive Orthopedics 510(k) for its Patient Specific 3D Printed Bone Segments for internal bone fixation in the ankle and foot. “Our lattice structures are proving to be the next generation design as opposed to the older, more open, types of structures that rely on biologics
Drugs
The Pennsylvania Superior Court says a Philadelphia County Common Pleas Court ruled correctly that a suit against Teva and its Cephalon unit alleging illegal off-label promotion of Actiq (fentanyl citrate) oral transmucosal lozenge is preempted under federal law and regulations. The suit claimed that a patient who was prescribed
FDA Policy/General
Federal Register notice: FDA has published a list of recent information collections that have been approved by OMB. Approved collections include: * Medical Devices; Humanitarian Use Devices * Medical Devices; Device Tracking * Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine * Certification to Accompany Drug,
Drugs
Federal Register notice: FDA is seeking public comments on an information collection extension entitled “Electronic User Fee Payment Request Forms — Form FDA 3913 and Form FDA 3914” (OMB control number 0910–0805). The request forms are designed to provide the minimum necessary information for FDA to review and process a
Drugs
FDA says there were 965 bioresearch monitoring inspections in FY 2017 — 97 performed by CBER, 581 by CDER, and 287 by CDRH. The numbers are included in a metrics report. The report says that common clinical investigator deficiencies were: * failing to follow the investigational plan/agreement or regulations or both;