Drugs
FDA has cleared a Resonea 510(k) for the Drowzle Sleep Apnea Pre-screening Device, a smartphone app that records and analyzes respiratory patterns during sleep for the purpose of in-home screening for obstructive sleep apnea. Results from the app are intended to be used to assist healthcare professionals
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Export of Medical Devices; Foreign Letters of Approval” (OMB Control Number 0910-0264). Requesters communicate with a representative of the foreign government to which they seek exportation, and written authorization must be obtained from the appropriate office
Drugs
FDA has released the FDA-483 issued following a 5/7-5/31 inspection at QuVa Pharma, a Bloomsbury, NJ, outsourcing facility. The six inspections observations were: * the quality control unit lacks responsibility to approve and reject all procedures or specifications affecting the identity, strength, quality, and purity of drug
FDA Policy/General
House Energy and Commerce Committee leaders are asking FDA to explain its slower than expected progress with manufacturers and providers of stem cell products to come into compliance with FDA’s guidance and premarket approval requirements, including those established by the 21st Century Cures Act. The 7/25 letter to
Drugs
Bristol-Myers Squibb says that part 2 of the Phase 3 CheckMate-227 trial did not meet the primary endpoint of overall survival with its Opdivo (nivolumab) plus chemotherapy versus chemotherapy in patients with first-line non-squamous non-small cell lung cancer, regardless of PD-L1 status. The company
Devices
FDA has published a guidance, Metal Expandable Biliary Stents — Premarket Notification (510(k)) Submissions, with recommendations for 510(k) submissions for metal expandable biliary stents and their associated delivery systems. The document says the devices are intended to provide luminal patency of the biliary tree for palliation of malignant strictures.
FDA Policy/General
Federal Register notice: FDA has set the following generic drug user fee rates for fiscal year 2020: ANDA ($176,237), drug master file ($57,795), domestic API facility ($44,400), foreign API facility ($59,400), domestic finished dosage form facility ($195,662), foreign finished dosage form facility ($210,662), domestic
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Export of Medical Devices; Foreign Letters of Approval” (OMB Control Number 0910-0264). Requesters communicate with a representative of the foreign government to which they seek exportation, and written authorization must be obtained from the appropriate office
Drugs
FDA has accepted for priority review an Epizyme NDA seeking accelerated approval for tazemetostat, indicated for treating metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery. The agency has set a user fee review action target date of 1/23/2020. The submission is based primarily on data
Drugs
Citing information from industry sources, multiple media outlets are reporting that the Trump administration is looking at ways to lower prices for almost all prescription drugs sold to Medicare and other government programs by tying prices the programs would pay to lower prices in other countries. Reuters says White House
FDA Policy/General
Federal Register notice: FDA is seeking comments on the agency’s publication of a glossary of terms which is part of the BEST (Biomarkers, Endpoints, and other Tools) Resource Taxonomy. FDA has developed a Web page that describes the resource, which links to the official National Library of Medicine Web
Drugs
FDA has approved an Eli Lilly NDA for Baqsimi (glucagon) nasal powder, the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that can be administered without an injection. “This new way to administer glucagon may simplify the process, which can be critical during an episode, especially since
Drugs
FDA has accepted for review a resubmitted Correvio Pharma NDA for Brinavess (vernakalant HCl, IV), an antiarrhythmic drug for rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults. The agency assigned a target PDUFA action date of 12/24. Correvio says the Brinavess NDA is supported
Devices
FDA has cleared a Life Spine 510(k) for the Prolift Expandable Spacer System. The device’s 8mm-10mm new widths more than double its current spinal options to accommodate a wider range of patients and their unique pathologies, the company says. It also features the company’s proprietary Osseo-
Devices
FDA says it is taking “significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)” by asking Allergan to recall specific models of its textured breast implants from the U.S. market. An agency statement says the company has indicated it is moving forward with
Drugs
FDA has established a docket to receive comments for 60 days on its publication of a glossary of terms that is part of the BEST (Biomarkers, Endpoints, and Other Tools) Resource Taxonomy. A Federal Register notice says FDA developed a Web page describing the BEST resource taxonomy and links to
Drugs
FDA has canceled a 7/31 meeting of its Psychopharmacologic Drugs Advisory Committee meeting that was scheduled to review an Intra-Cellular Therapies NDA for lumateperone tosylate capsules for treating schizophrenia. The company says the panel meeting was canceled to give FDA reviewers time to review FDA-requested additional information
Drugs
Loyola Law School professor Adam Zimmerman says the Supreme Court decision in Merck v. Albrecht demonstrates how the issue of federal preemption transcends the typical conservative and liberal positions. Writing online in The Regulatory Review, Zimmerman says Albrecht was a case of “impossibility preemption” in which the company said it
Devices
Maquet/Datascope is recalling all Intra-Aortic Balloon Pumps (IABP) due to reports of the IABP batteries failing to hold a charge, stopping unexpectedly, and having a shortened run-time which may cause the device to stop working when being operated by battery only. The recall is being conducted to
Biologics
FDA has approved a Samsung Bioepis BLA for Hadlima (adalimumab-bwwd), a biosimilar referencing Abbott’s Humira for treating rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. Hadlima will be commercialized in the U.S. by Merck, and is expected
Drugs
Federal Register notice: FDA has submitted to OMB an information collection extension for “Clinical Laboratory Improvement Amendments (CLIA) Waiver Applications” (OMB Control Number 0910-0598). CLIA establishes quality standards for all laboratory testing, and it requires that clinical laboratories obtain a certificate before accepting materials derived from the human body
FDA Policy/General
FDA acting commissioner Ned Sharpless has outlined key agency priorities that include supporting emerging technologies, investing in the agency’s next generation expert workforce and infrastructure, and promoting and protecting consumer and patient safety. In a 7/23 FDA-wide email, Sharpless said the agency’s guiding principles continue to