Drugs
In a wide-ranging interview with the NTD global television network, FDA commissioner Robert Califf said that it is very difficult for states to meet the criteria established by Congress to permit bulk drug importation from Canada. Asked whether he expected importation to gain traction now that the agency has
Devices
FDA says it has received reports of adverse events associated with electrical operating room tables, including problems with positioning or unintended movement of the table that may result in serious patient injury, or extended or delayed surgical procedures that can lead to potentially life-threatening complications. “While FDA believes that
Drugs
Former pharmacy compounder Patient Care America (PCA) CEO and president Patrick Smith (Palm Beach Gardens, FL) was sentenced to six months in prison for lying to federal agents who were investigating PCA for various health care fraud offenses. The FDA Office of Criminal Investigations case investigated PCA over health care
Devices
Wipro GE Healthcare Private Ltd. is recalling (Class 1) its Care Plus and Lullaby Incubators due to the device’s bedside panel or porthole not properly latching closed. “If a bedside panel or porthole is not latched properly, the panel can detach and open, no longer protecting the patient from
Devices
FDA investigators found issues with record keeping and quality control for animals at a California animal research facility operated by Elon Musk’s Neuralink. Reuters reports the issues were found less than a month after the agency cleared Neuralink to begin testing its brain implant in humans. Based on agency
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form FDA 3601a.” Form FDA 3601 is designed to provide the minimum necessary information to determine whether a fee is required
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Export Certificates for FDA Regulated Products.” Regulatory provisions require the agency to issue written export certifications for medical devices within 20 days of a request. To offset the agency resource commitments, it may charge firms a fee
Devices
FDA has issued a safety alert on a higher-than-expected risk of device failure with DT MedTech’s Hintermann Series H3 Total Ankle Replacement (TAR) system. The agency says it is evaluating interim post-approval study (PAS) results on the device and other real-world data. “For patients with
Biologics
CBER director Peter Marks is predicting that 2024 will be a “breakout year” for gene therapy approvals as several initiatives work to advance the development of such products. Speaking 2/26 at the BioPharma Congress, Marks said, “What we are trying to accomplish this year is taking a number of
Drugs
The Association for Accessible Medicines raises these concerns about an FDA draft guidance on quality considerations for topical ophthalmic drug products: * identification and qualification thresholds; * validation of analytical methods for extractables; and * acceptance criteria for leachables. Alcon updates its comments, questions, requests for clarification, and general comments in a table
Devices
Stakeholders are expressing concerns about an FDA 11/30/2023 proposed rule on medical device wound products. The DuVal & Associates law firm says the proposed rule “imposes requirements on wound product clearances/approvals to address an unsubstantiated concern. The proposed rule addresses the issue of antimicrobial resistance and its
Drugs
FDA commissioner Robert Califf says he is very concerned about the prevalence of compounded and fake versions of the new weight-loss drugs such as Novo Nordisk’s Wegovy (semaglutide) and Lilly’s Zepbound and Mounjaro (tirzepatide). In a Reuters interview, he says that consumers seeking the branded medications are
Devices
FDA has cleared a Nevro 510(k) for its Nevro1 sacroiliac (SI) joint fusion device for treating chronic SI joint pain. The company says the device is proven to “immediately transfix the SI joint to allow the opportunity for long-term fusion. Self-contained, deployable titanium anchors transfix the sacrum
Devices
Medtronic Neurology has recalled (Class 1) its Duet External Drainage and Monitoring System, which is used to drain cerebrospinal fluid (CSF) to reduce intracranial pressure and CSF volume, due to the potential for catheter disconnection from patient line stopcock connectors. An FDA recall notice notes that the cause of the
Drugs
A RAND study funded by HHS finds that nearly 85% of new drugs sold in the U.S. were sold here either first or in the same quarter in which they were introduced in other Organization for Economic Cooperation and Development countries. The study analyzed data on prescription drug availability
FDA Policy/General
Federal Register notice: FDA is issuing an order to reduce a five-year debarment against former Indivior global medical director Timothy Baxter. The agency says the debarment will now end 10/26/2025, three years earlier than originally ordered, due to a “mutual agreement of the parties.” The debarment was
FDA Policy/General
A lengthy Food & Drug Law Institute (FDLI) analysis shows how two fisheries cases before the Supreme Court could lead to major changes in the regulatory landscape for FDA and other federal agencies. The report says the high court appears poised to at least significantly modify, if not eliminate, the
Drugs
FDA has accepted for priority review an Applied Therapeutics NDA for AT-007 (govorestat) for treating classic Galactosemia. Govorestat is described as a central nervous system penetrant aldose reductase inhibitor. The agency has set a user fee review action target date of 8/28. Galactosemia is a rare genetic metabolic
Drugs
An 8/7-8/15/2023 FDA inspection at the Amman Pharmaceutical Industries drug manufacturing facility in Amman, Jordan, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 2/14 Warning Letter says specific violations were: * failing to perform operations within specifically defined areas of
Drugs
FDA says its testing of samples of LightEyez MSM eye drugs obtained through the company’s Web site found that the product is adulterated because “it consists in whole or in part of any filthy, putrid, or decomposed substance.” A 2/15 Warning Letter says the company is headquartered in
Drugs
FDA says it inspected Delsam Pharma in Mamaroneck, NY, and EzriCare in Lakewood, NJ, after an agency inspection revealed violative conditions at Global Pharma Healthcare Private Limited, a contract manufacturing organization used to manufacture ophthalmic drugs for Delsam and EzriCare. FDA issued 2/13 Warning Letters to Delsam and EzriCare
Drugs
FDA has denied a 12/2/2020 Boehringer Ingelheim petition asking that the agency: * interpret the term “strength” in a section of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) relating to parenteral solutions to mean the total drug content in the relevant container; and * revise applicable guidance