Drugs
A Miami, FL, woman who co-owned Unlimited Medical Research, a clinical research site, pleaded guilty 1/12 to obstructing a 2017 FDA regulatory inspection with an alleged scheme to fraudulently falsify clinical trial data. The Department of Justice says that as part of a plea agreement, Olga Torres admitted
Drugs
FDA has cleared a G-Tech Medical 510(k) for its Wireless Patch System for myoelectric activity measurement. The device is intended to provide gastric and intestinal myoelectrical activity measurements to aid in the diagnosis and evaluation of gastrointestinal disorders. “Gastrointestinal motility is the underlying factor in a wide range
FDA Policy/General
Federal Register notice: FDA is revoking the Emergency Use Authorizations (EUAs) issued to Becton, Dickinson (BD) for the BioGX SARS–CoV–2 Reagents for BD MAX System, Boston Medical Center (BMC) for the BMC–CReM COVID–19 Test, and Akron Children’s Hospital (ACH) for the Akron Children’s Hospital
FDA Policy/General
The Senate Health, Education, Labor & Pensions Committee 1/13 voted 13 to 8 to move FDA commissioner nominee Robert Califf’s nomination to an eventual Senate floor vote. On the Democrat side, two votes were against the nomination — Bernie Sanders (I-VT) and Maggie Hassan (D-NH). This was
Drugs
FDA has released the FDA-483 issued following a 9/16-9/28/21 inspection at SSM Health Care St. Louis, doing business as SSM St. Clare Health Center, a Fenton, MO, outsourcing facility. The four inspection observations were: * written records of investigations into the failure of a batch or
Devices
FDA has updated its 12/2020 safety communication on Endologix’s AFX endovascular graft systems used in treating abdominal aortic aneurysms (AAA) and the risks associated with Type III endoleaks with the devices. The update includes an information summary from the agnecy’s 11/2021 advisory committee meeting and new
Devices
FDA has approved Mentor’s MemoryGel Boost Breast Implant for breast augmentation in women at least 22 years old, and for women of all ages undergoing breast reconstruction. The company says the device features its “proprietary highly cohesive gel, an innovative implant shell design and precision fill ratio, the combination
Biologics
FDA says it has revised the Janssen Covid-19 vaccine fact sheet for healthcare providers administering vaccines and the fact sheet for recipients and caregivers. The agency says the revisions are in response to new safety information about the serious risk of immune thrombocytopenia, a disorder that can cause easy
Devices
FDA has approved a request from the Florida state government to extend the expiration date on hundreds of thousands of expired Covid test kits by three months into March. Florida News reports the state’s Division of Emergency Management has between 800,000 and one million test kits that had
Drugs
FDA is warning patients and prescribers about the potential for dental problems associated with buprenorphine drugs dissolved in the mouth to treat opioid use disorder and pain. An agency statement says problems including tooth decay, cavities, dental abscesses/infection, tooth erosion, and, in some cases, total tooth loss, have been
Drugs
FDA has accepted for priority review a Mitsubishi Tanabe Pharma America NDA for edaravone (MT-1186) for treating amyotrophic lateral sclerosis (ALS). The company says that oral edaravone has been developed to have a similar clinical profile compared to the intravenous formulation of Radicava (edaravone), which was approved by the
Drugs
Washington University in St. Louis law professor Rachel Sachs says the Center for Medicare and Medicaid Services (CMS) decision to propose restricting Medicare coverage of Biogen’s Aduhelm (aducanumab) “is likely … to fuel criticism of FDA’s accelerated approval program and its relationship to payers.” Writing in an online Health
Drugs
Novartis and Molecular Partners are planning to seek an FDA emergency use authorization after reporting results from the EMPATHY clinical trial that compared single intravenous doses of ensovibep, a DARPin antiviral therapeutic candidate, compared with placebo in treating Covid-19. Trial data showed that the therapy met the primary endpoint
Drugs
Harvard Medical School researchers say the FDA process of allowing generic drug manufacturers to market versions with so-called skinny labels that exclude patent-protected indications allowed generic versions of Novartis’ Gleevec (imatinib) to enter the market before patent protections for treating gastrointestinal stromal tumors (GIST) expired. Writing in the
Drugs
FDA has accepted a PharmaTher investigator-initiated IND to proceed with a Phase 2 trial to evaluate ketamine to treat amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. The company says the agency previously had granted an orphan drug designation for ketamine to treat ALS. If the
FDA Policy/General
Federal Register notice: FDA is issuing a final rule to revoke the regulations for human tissue intended for transplantation and human dura mater recovered prior to 5/25/2005. The revocation does not affect regulations for human cells, tissues, and cellular and tissue-based products recovered on or after May
FDA Policy/General
Federal Register notice: FDA has issued a final rule to amend the medical device regulations on procedures for announcing approvals and denials of PMAs and HDEs. The final rule discontinues the publication in the Federal Register each quarter of a list of recent PMA and HDE approvals and denials. Instead,
Devices
FDA has cleared an Abbott 510(k) for the EnSite EP System with EnSite Omnipolar Technology (OT), a new cardiac mapping platform designed to help physicians better treat cardiac arrhythmias. The device creates “highly detailed” three-dimensional maps of the heart to help physicians identify and then treat areas of
Drugs
FDA has released the FDA-483 issued following a 7/7-7/27/21 inspection at Med Shop Total Care, a Longview, TX, producer of sterile and non-sterile drugs. The specific observations were: * failing to make adequate product evaluation and take remedial action where actionable microbial contamination was found
Drugs
FDA and the Duke-Margolis Center for Health Policy published 12/15/21 the summary of a 10/2019 workshop “Enhancing the Accessibility and Utility of Drug Interaction Information in Prescription Drug Labeling.” The summary highlights the discussion of workshop participants about challenges in managing drug interactions in the clinical
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act. The agency requires device manufacturers to notify it about a permanent discontinuance or an interruption in a
Drugs
Two professors in the University of Pennsylvania Perelman School of Medicine and Boston University School of Law say the FDA accelerated approval process is “worth saving, but fixes are needed to make sure companies quickly follow through on rigorous confirmatory studies” of the drugs receiving accelerated approval. Writing in a