Drugs
FDA Chief Scientist Namandjé N. Bumpus has proposed an advisory committee review to address a 2021 CDER decision not to approve an NDA submitted by Intarcia Therapeutics for ITCA 650 (exenatide in DUROS device), a drug/device combination product intended to deliver exenatide, a GLP-1 receptor agonist, as an
Devices
A 5/23-5/26/22 FDA inspection at MicroVention Costa Rica, in Alajuela, Costa Rica, found Quality System regulation violations in the firm’s manufacturing of microcatheters and balloon catheters. A just-released 9/30/22 Warning Letter says specific violations were: * failing to verify a process that cannot
Devices
A 7/18-7/21/22 FDA inspection at Getsch+Hiller Medizintechnik in Nendingen, Germany, found Quality System regulation and other violations in the firm’s manufacturing of monopolar laparoscopic instruments with disposable and reusable instrument tips. A just-released 12/27/22 Warning Letter lists the specific violations as:
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “FDA Administrative Practices and Procedures; Formal Hearings.” The collection supports FDA regulations associated with the Administrative Procedures Act that cover formal evidentiary, public, and regulatory hearings. To view the notice, click here.
Devices
FDA has revised its online guide on when and how often people should use an over-the-counter at-home Covid-19 test to encourage users to self-report their test results at MakeMyTestCount.org. The agency says that each test result should be reported only one time, and it
Biologics
FDA has approved a Takeda supplemental BLA for an expanded use of Takhzyro (lanadelumab-flyo) — prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients aged two to 11 years of age. Previously, the drug was approved for prophylaxis treatment in adults and children aged six to 11 years.
FDA Policy/General
Federal Register notice: FDA has determined that 31 drug products were not withdrawn from sale due to safety or effectiveness reasons. The determinations permit the agency to approve ANDAs that reference the products as long as they meet relevant legal and regulatory requirements. To view the notice, click here.
Drugs
FDA has accepted for priority review a Biogen and Sage Therapeutics, NDA for zuranolone, a rapid-acting once daily oral drug for major depressive disorder (MDD) and postpartum depression (PPD). The agency has set a user fee review action target date of 8/5. “Most current approved therapies may take
Devices
A citizen petition from the Clinical Decision Support (CDS) Coalition asks FDA to rescind its controversial 9/2022 final guidance on “Clinical Decision Support Software” (see earlier story) because it violates the Federal Food, Drug, & Cosmetic Act (FD&C Act). The group says FDA should repropose the CDS
Drugs
Former physician Deepak Raheja (Hudson, Ohio) was sentenced 2/3 to 30 months in prison after pleading guilty to pharmaceutical kickback conspiracy charges involving two Avanir Pharmaceuticals sales representatives. Raheja was ordered to surrender his medical license, pay $2.1 million in restitution, and a $50,000 fine. Between 2/
Devices
FDA has approved an Abbott expanded indication for its FlexAbility Ablation Catheter, Sensor Enabled, a flexible tip catheter intended to help physicians identify abnormal signals and apply therapy to treat ventricular tachycardia (VT) in patients with non-ischemic cardiomyopathy (NICM). The company says NICM is a type of heart muscle
Drugs
FDA has approved AstraZeneca and Amgen’s Tezspire (tezepelumab) in a self-administration pre-filled, single-use pen for patients aged 12 years and older with severe asthma. Approval was based on data from the PATHFINDER clinical trial program, which showed that the majority (92%) of healthcare providers, patients and
FDA Policy/General
Federal Register notice: FDA has announced a 3/28-29 public workshop entitled “Understanding Priorities for the Development of Digital Health Technologies To Support Clinical Trials for Drug Development and Review.” It is being convened by the Duke-Robert J. Margolis, MD Center for Health Policy under a cooperative agreement
FDA Policy/General
Federal Register notice: FDA has announced a 5/11 public workshop entitled “FY 2023 Generic Drug Science and Research Initiatives Workshop,” which will provide an overview and the status of science and research initiatives for generic drugs. The workshop will also provide an opportunity for public input on the research
Biologics
FDA has accepted for filing a Sandoz BLA for a biosimilar version of Amgen’s denosumab (Prolia and Xgeva), which includes all indications for the reference drugs, including osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal-related complications in
Drugs
FDA has placed a clinical hold on 4D Molecular Therapeutics’ 4D-310 drug being studied for treating Fabry Disease Cardiomyopathy after the company reported three patients experiencing atypical hemolytic uremic syndrome, a condition that affects kidney function and causes blood clots to form. The company says that it stopped enrollment
FDA Policy/General
Federal Register notice: FDA is making available an annual report entitled “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.” The report is mandated by the FD&C Act to provide the status of postmarketing requirements and postmarketing commitments that are required of
Devices
A new 2022 annual report on CDRH’s Accreditation Scheme for Conformity Assessment (ASCA) pilot program says it will transition to a permanent program based on demonstrated review efficiencies. ASCA encourages device sponsors to use FDA-recognized voluntary consensus standards in their submissions because they reduce regulatory burden and promotes
Drugs
An FDA Office of Criminal Investigations felony case involving a Mays Landing, NJ, man who marketed online a toxic chemical as a weight-loss drug has led to a guilty plea on an obstruction of justice charge after he submitted fictitious medical records and doctor’s letters to the court
Devices
The Department of Justice (DoJ) says medical device manufacturer Joint Active Systems (JAS), of Effingham, IL, has agreed to pay $500,000 to settle civil claims under federal and North Carolina False Claims Acts concerning allegations that it caused submission of false claims to North Carolina’s Medicaid program. DoJ
Drugs
FDA has approved a Gilead Sciences supplemental BLA for Trodelvy (sacituzumab govitecan-hziy) for treating adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies
Drugs
Senator Jeanne Shaheen (D-NH) led eight senators in a 2/1 letter to Danco Laboratories, a manufacturer of mifepristone, urging it to submit a supplemental NDA to add miscarriage management to the medication’s label. “Currently, mifepristone’s label includes medication abortion, but it can also be safely and