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FDA has issued a draft guidance, Material Threat Medical Countermeasure Priority Review Vouchers, to answer questions raised about a 21st Century Cures provision requiring the agency to award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applications notified the agency that the drug products were no longer marketed and requested that their approval be withdrawn.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.
Drugs
FDA says it is working with the Department of Defense (DoD) to prioritize efficient development of medical products intended to save the lives of American military personnel. A FDA announcement says the program framework comes through legislation that authorized the Defense Department to request, and FDA to provide, assistance to
Drugs
A 7/31-8/3/17 FDA inspection at Shanwei Honghui Daily Appliance Co., Ltd., Shanwei, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 12/5/17 Warning Letter. Specific violations cited in the letter were: * failing to clean, maintain, and,
Drugs
An FDA drug safety alert says Tesaro’s Varubi (rolapitant) injectable emulsion has been associated with anaphylaxis and other serious hypersensitivity reactions. The product is approved to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). The reactions have occurred during or soon after the infusion of Varubi, with most
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Becton Dickinson Franklin Lakes, NJ (1/11): FDA inspected the firm 7/2017 and determined that the firm did not gain clearance for device modifications to its BD Vacutainer
Devices
The Department of Justice (DoJ) says a second individual has pleaded guilty in connection with a scheme to defraud consumers by selling laser devices as a treatment for more than 200 different diseases and disorders. A department news statement says Irina Kossovskaia, of Ontario, Canada, pleaded guilty in South Dakota
Drugs
FDA has launched a new pilot to offer more transparency with drug approval decisions. “One place where we are evaluating how we can release information that may better inform scientists, providers, and patients is clinical study reports (CSRs),” FDA commissioner Scott Gottlieb said 1/16. A CSR is the portion
Devices
Sens. Edward Markey and Elizabeth Warren (both D-MA) have reintroduced legislation (S. 2287) to eliminate the 2.3% excise tax on medical devices. The tax first took effect 1/2013 as part of the Affordable Care Act. Congress suspended it for 2016 and 2017, but it was reinstated 1/
Drugs
A 5/22-5/26/17 FDA inspection at Wuhan Chinese Moxibustion Technology Dev. Co., Ltd., Wuhan, Hubei, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 12/18/17 Warning Letter. Specific violations cited in the letter were: * failing to establish