Drugs
HHS and 15 other federal agencies say they are delaying for six months from 1/19 to 7/19 the general compliance date for 2018 revisions to the Federal Policy for the Protection of Human Subjects that is in a final rule published 1/19/17. A Federal Register notice
Drugs
FDA says AuroMedics Pharma is recalling one lot of levofloxacin in 5% dextrose injection 250mg/50mL in a single-use flexible container that has been found to contain visible particulate matter tentatively identified as mold. An agency statement says the problem was discovered as a result of a product complaint
Drugs
Almost half of FDA employees would be ordered to stay home under a current budget impasse if Congress and president Donald Trump can’t come to terms by midnight 1/19 on funding for fiscal year 2018. It is possible that a continuing resolution could be negotiated that would delay
Devices
FDA has cleared an International Biophysics 510(k) for the FloPump 32 centrifugal disposable heart pump. The company says the single-use device is one of the smallest centrifugal pumps in the world at 32ml prime, and it is intended to be used in conjunction with the Maquet RotaFlow console.
Devices
FDA has cleared a Medtronic 510(k) for the Riptide Aspiration System for use in retrieving blood clots through the Arc catheter and restoring blood flow in patients experiencing blockage of an artery in the brain (ischemic stroke). The procedure involves inserting a catheter through an incision in the leg
Drugs
Three FDAers say many researchers are unaware of FDA regulatory science research opportunities and the need for collaboration. Writing in Trends in Pharmaceutical Sciences, the three say the agency has “multiple avenues for collaborative research including participation in public-private partnerships, working with consortia, implementation of research collaboration agreements with
FDA Policy/General
The Senate Finance Committee voted 15-12 to recommend to the full Senate the nomination of Alex Azar as HHS secretary, succeeding Tom Price, who was forced to resign after reports that he routinely flew in chartered jets at taxpayer expense. Observers believe Azar will win the nomination in the
Devices
An FDA safety alert is warning health professionals about Zoll Medical’s Zoll LifeVest 4000 Wearable Cardioverter Defibrillator due to concerns that the device may fail to deliver treatment to the patient if the device is not replaced soon after displaying a “call for service” message code 102. Failure to
Drugs
FDA has accepted for priority review a Novartis supplemental BLA for Kymriah (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for, or relapse after, autologous stem cell transplant. Kymriah was the first CAR-T cell
Drugs
FDA has approved an Amgen supplemental NDA to add overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial to the prescribing information for Kyprolis (carfilzomib). The data demonstrated that Kyprolis and dexamethasone reduced the risk of death by 21% and increased OS by 7.6 months
Devices
The Government Accountability Office (GAO) says FDA should develop and use performance metrics to evaluate its implementation of the requirement that it consider the least burdensome means of evaluating a medical device. FDA commissioner Scott Gottlieb says he agrees with the findings of the GAO report. The report describes (1)
Drugs
FDA has issued a draft guidance, Material Threat Medical Countermeasure Priority Review Vouchers, to answer questions raised about a 21st Century Cures provision requiring the agency to award a priority review voucher to sponsors of certain medical countermeasure applications that meet the criteria specified in the law. The question-and-
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 22 ANDAs from multiple applicants. The holders of the applications notified the agency that the drug products were no longer marketed and requested that their approval be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register proposed rule: FDA has proposed to implement regulations regarding internal agency supervisory review of certain decisions related to devices regulated by CDRH. FDA is taking this action to codify the procedures and timeframes for supervisory review of significant decisions pertaining to devices within CDRH. FDA is also proposing
FDA Policy/General
Federal Register notice: FDA has submitted for OMB clearance a new information collection entitled “Use of Public Human Genetic Variant Databases To Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics — OMB Control Number 0910.” The information collection supports a similarly titled guidance document that describes the agency’
Drugs
Baxter International has expanded its 11/2017 recall of one lot of Nexterone (amiodarone HCl) 150 mg/100 mL premixed injection to include a second lot due to the potential presence of particulate matter. Affected lots were distributed between 7/21/2017 and 10/2/2017 in the U.S.
Drugs
FDA says promotional materials for a number of compounded drug products — Dropless products, LessDrops products, Simple Drops products, and Klarity C-Drops product — marketed by Imprimis Pharmaceuticals, San Diego, CA, make many false or misleading claims. The claims establish that the products are drugs, according to a 12/21/17
Devices
CDRH says its strategic priorities for 2018-2020 are (1) employee engagement, opportunity, and success; (2) simplicity; and (3) collaborative communities. The Center’s strategic priorities document says the employee priority recognizes the connection between taking care of Center employees and achieving the Center’s vision. Simplicity is about how
Drugs
A 3/27-3/31/17 FDA inspection at Delta Laboratories Pty. Ltd., Somersby, Australia, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 12/19/17 Warning Letter. Specific violations cited in the letter were: * failing to thoroughly investigate any unexplained discrepancy
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices.” The document describes FDA’s intention to not enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements before 9/24/2020.
FDA Policy/General
Federal Register notice: FDA has announced a 5/22-23 public workshop on “Accreditation Scheme for Conformity Assessment of Medical Devices to FDA-Recognized Standards.” The workshop is intended to discuss and obtain input and recommendations from stakeholders on the draft accreditation scheme, including its goals and scope, a suitable
FDA Policy/General
Federal Register notice: FDA has proposed to delay the effective date of certain portions of a final rule published in the 1/9/2017 Federal Register that amended the agency’s existing regulations describing the types of evidence that may be considered in determining a medical product’s intended uses.