Devices
FDA has dismissed concerns raised in a JAMA Internal Medicine report (see earlier story) that many medical device adverse event reports (MDRs) involving a patient death are classified in categories other than death in the agency’s Manufacturer and User Facility Device Experience (MAUDE) database. An FDA spokeswoman told FDA
Devices
FDA has cleared a TransMedics Group 510(k) for its OCS Lung Solution for use in transplants using cold storage techniques. The device is indicated for hypothermic flushing, storage and transportation of donor lungs for transplantation, according to the company. It is a colorless, sterile, pyrogen-free, colloid-based extracellular
Drugs
FDA has approved GlaxoSmithKline’s Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5, as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The new indication for mepolizumab is for the add-on maintenance treatment of CRSwNP in adult patients 18 years of age and older with
Biologics
FDA is allowing Emergent BioSolutions to resume production of the Johnson & Johnson Covid-19 vaccine at the company’s troubled Bayview manufacturing facility. The company says that following an FDA order to halt vaccine production at Bayview, it worked closely with the agency and J&J to address
Drugs
FDA has approved Mylan’s Semglee (insulin glargine-yfgn), the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes and adults with Type 2 diabetes. An agency notice says Semglee is biosimilar to and interchangeable with Sanofi’s Lantus (insulin
FDA Policy/General
Federal Register notice: FDA determines that Eli Lilly’s Ceclor CD (cefaclor extended-release tablets) 375 mg and 500 mg were not withdrawn from sale for reasons of safety or effectiveness, except for the indication “secondary bacterial infections of acute bronchitis.
FDA Policy/General
Federal Register notice: CDER and CBER are announcing the effective date of 9/15 for using Electronic Common Technical Document (eCTD) validations referenced in FDA’s “Technical Rejection Criteria for Study Data.” FDA says that submissions that are not submitted electronically and electronic submissions that are not in a format
FDA Policy/General
Federal Register notice: FDA has determined that Bausch Health America’s Efudex (fluorouracil) topical solution, 5%, was not withdrawn from sale for reasons of safety or effectiveness. The determination means that FDA can continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis.” The document is intended to help sponsors in developing anti-rabies virus monoclonal antibody cocktails as an alternative to anti-rabies virus immunoglobulin as the
Drugs
Four senators — Chuck Grassley (R-IA), Amy Klobuchar (D-MN), Angus King (I-ME), and Susan Collins (R-ME) — are calling on HHS secretary Xavier Becerra to support policies that would allow Americans to personally import certain prescription drugs from Canada. Their 7/26 letter follows a presidential executive order
Devices
Washington Legal Foundation (WLF) is asking the 1st Circuit Court of Appeals to reverse on First Amendment grounds the criminal convictions of two former medical device company executives under the Federal Food, Drug, and Cosmetic Act (FFDCA). WLF submitted an amicus brief on behalf of the two Acclarent former executives
Drugs
FDA has approved an Allergan label expansion for Botox to include eight new muscles for treating upper limb spasticity in adults. The company says the new muscles include those in the elbow and forearm (brachialis, brachioradialis, pronator teres, and pronator quadratus), as well as intrinsic hand muscles (lumbricals and interossei)
Drugs
FDA approved a modification to the clozapine REMS (risk evaluation and mitigation strategy) 7/29 to become effective 11/15. An agency notice says FDA continues to work with the Clozapine Product Manufacturing Group to ensure that patients relying on clozapine have continued access to the medication and appropriate management
Biologics
FDA has released the transcript of a 5/6 virtual workshop on “Patient Engagement & Regenerative Medicine: A CBER Workshop for Patient Advocates.” The workshop was hosted by CBER’s Office of Tissues and Advanced Therapies (OTAT). During the session, OTAT deputy director Rachael Anatol said cell and gene therapy-
Devices
FDA has cleared a Volpara Health 510(k) for the latest version of its key science algorithm, Volpara Imaging Software (VIS 3.2), a breast density assessment algorithm that incorporates learnings from artificial intelligence. The company says the clearance also expands the software’s use on additional mammography machines, increasing
Biologics
FDA has accepted for a priority review a Genentech BLA for faricimab for treating wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). The company says faricimab will be the first bispecific antibody designed for the eye. It is designed to target two distinct pathways — via
Devices
Researchers at the University of California San Francisco and other locations say that many medical device adverse event reports that involve a patient death are classified in categories other than death in the FDA Manufacturer and User Facility Device Experience (MAUDE) database. “As FDA only routinely reviews all adverse events
Drugs
The International Council for Harmonization (ICH) Q13 guidance on continuous manufacturing of drug substances and drug products completed step 2 of the ICH process 7/27 and is now available for public review and comment. An ICH online post (contains a link to the guidance) says the document describes scientific
FDA Policy/General
Federal Register notice: FDA has announced the generic drug user fee rates for fiscal year FY 2022. The rates are: ANDA ($225,712), drug master file ($74,952), domestic API facility ($42,557), foreign API facility ($57,557), domestic finished dosage form facility ($195,012), foreign finished dosage form facility
FDA Policy/General
Federal Register notice: FDA has issued a five-year debarment order against Justin Ash due to his felony conviction for illegal importation of a drug or controlled substance through his internet-based business entity known as both DRC and Domestic RCS. To view the notice, click here.
Biologics
FDA has issued a draft guidance, Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis, to help sponsors develop such cocktails as an alternative to anti-rabies virus immunoglobulin as the passive immunization component of post-exposure prophylaxis for the prevention of rabies when given
Devices
FDA has cleared two Medtronic AccuRhytm AI algorithms for use with the LINQ II insertable cardiac monitor. The company says the AccuRhythm AI applies artificial intelligence (AI) to heart rhythm event data collected by LINQ II, improving the accuracy of information doctors receive so they can better diagnose and treat