Drugs
Manatt Health senior advisor Ian Spatz says the FDA proposal to create a process for agency approval of state-sponsored drug importation plans is not likely to generate significant savings for states or even enough to justify the cost of establishing such a program. Writing online in Stat, Spatz says
FDA Policy/General
Comments Extended on Combo Product Bridging Guide Federal Register notice: FDA extends until 4/20 the comment period for a 12/2019 draft guidance on Bridging for Drug-Device and Biologic-Device Combination Products. 02/14/2020 28 ‘No Longer Marketed’ ANDAs Withdrawn Federal Register notice: FDA withdraws approval of
FDA Policy/General
Boehringer Ingelheim has launched opnME.com, a new platform offering free and open access to selected pre-clinical molecules for non-clinical investigation to scientists worldwide. The company says the platform contains molecules for some of the most relevant targets in biomedical research, and they are being shared to foster
FDA Policy/General
DEVICES FDA has cleared a 4WEB Medical 510(k) for its Lateral Spine Truss System, a 3D-printed lateral interbody fusion device. “4WEB’s proprietary truss implant technology leverages fundamental engineering principles in structural mechanics to address important clinical issues such as implant subsidence after lateral access surgery,” a news
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of 28 ANDAs from multiple applicants. The applicants notified the agency that the products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has extended until 4/20 the comment period for a 12/2019 draft guidance on Bridging for Drug-Device and Biologic-Device Combination Products. The guidance seeks to clarify how to bridge the information gathered from another development program to leverage that information in support of
Devices
CDRH has announced a 4/13-15 public workshop entitled “Towards Good Simulation Practices in Health Technologies” that will discuss modeling and simulation practices currently used in health technologies by the device industry. “The key topics to be discussed are the role of computational modeling and simulation in the regulatory
FDA Policy/General
As part of its efforts to understand recent lung injuries associated with certain vaping products, FDA has opened a docket to obtain data and information on such injuries to help identify and evaluate additional steps the agency could take. The agency says it is seeking “unpublished data or information related
Drugs
After recently meeting with FDA in a Type C meeting, Sellas Life Sciences Group says it has finalized the design and plan for a Phase 3 study of nelipepimut-S (NPS) vaccine in combination with trastuzumab (Genentech’s Herceptin) for treating patients with triple negative breast cancer in the adjuvant
Devices
FDA has granted Bluegrass Vascular Technologies a de novo marketing order for its Surfacer Inside-Out Access Catheter System. The device is intended to obtain central venous access to allow catheter insertion into the central venous system for patients with upper body venous occlusions or other conditions that preclude access
Drugs
FDA has accepted for review an Epizyme supplemental NDA seeking accelerated approval for Tazverik (tazemetostat), a methyltransferase inhibitor, for patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior lines of systemic therapy. Tazverik gained its first accelerated approval last month for adults and pediatric
Drugs
FDA has accepted for review a FibroGen NDA for roxadustat for treating anemia associated with chronic kidney disease (CKD), in both non-dialysis-dependent and dialysis-dependent patients. The agency has set a user fee review action target date of 12/20. The NDA filing triggers a $50 million milestone
Drugs
FDA says it is keeping a close eye on the medical product supply chain during the current coronavirus outbreak. “We are keenly aware that the outbreak will likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S.,"
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Peripheral Vascular Atherectomy Devices — Premarket Notification Submissions.” The document provides recommendations for premarket submissions for a new or modified device. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has requested that industry organizations interested in participating in selecting nonvoting industry representatives to serve as temporary nonvoting members on CDRH’s Patient Engagement Advisory Committee notify it in writing. Nominees recommended to serve as a temporary nonvoting industry representative may either be self-nominated or
Drugs
The White House Council of Economic Advisers (CEA) says that foreign “free-riding” on U.S. investments and innovations in drug development has increased over the last 15 years. In a report, “Funding the Benefits to Biopharmaceutical Innovation,” CEA argues that if developed countries did not pay below the value
Drugs
Researchers from FDA and two universities say that pharmacogenomic information included on drug labels can facilitate a better understanding of pharmacogenomics among researchers, healthcare professionals, and the public, to advance the science of precision medicine. Writing in Drug Discovery Today, the researchers provide an overview of pharmacogenomic information in 362
Drugs
FDA has accepted for priority review a Seattle Genetics NDA for tucatinib for use in combination with trastuzumab and capecitabine for treating patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least three prior HER2-directed agents separately or
Biologics
FDA has accepted for priority review a Bristol-Myers Squibb BLA for lisocabtagene maraleucel, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell immunotherapy with a defined composition of purified CD8+ and CD4+ CAR T cells for treating adult patients with relapsed or refractory large B-cell lymphoma after
Devices
FDA has approved an Orthofix Medical PMA for the STIM onTrack mobile app version 2.1 for use with the company’s bone growth stimulators. The mobile device app is an accessory designed to help patients adhere to their prescriptions and improve their clinical outcomes, the company says. The new
Devices
FDA has classified as Class 1 a Tytek Medical recall of its PneumoDart, a compact, sterile, device that the agency says is “intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.” A recall notice
Drugs
FDA is asking Eisai to withdraw its weight-loss drug Belviq (lorcaserin) and Belviq XR from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. An agency drug safety communication says Eisai has submitted a request to voluntarily withdraw the drug. The agency says