Devices
FDA has cleared a K2M Group Holdings 510(k) for its Mojave PL 3D Expandable Interbody System, a 3D-printed expandable posterior-lumbar interbody system that features the company’s Lamellar 3D Titanium Technology. The fusion device is designed to allow for independent control of the anterior and posterior height
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) describing Office of Generic Drugs policies and procedures for reviewing bioequivalence studies with clinical endpoints submitted in ANDAs. The document says before 2000, all comparative clinical endpoint studies submitted in ANDAs were referred to the appropriate Office of New Drugs
Devices
Merit Medical Systems has received de novo clearance from FDA to expand the indication for its Embosphere Microspheres to now include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia. The PAE procedure is performed through a tiny incision in the patient’s upper thigh or wrist, and uses Embosphere
Devices
FDA has approved LivaNova’s VNS Therapy systems for expanded MRI labeling, allowing patients to visit any MRI center in the U.S. and have access to more than 90% of scans routinely performed on patients with epilepsy. Previously, approved labeling allowed patients to obtain MRI scans only with the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Application for Participation in FDA Fellowship Programs.” The collection involves brief online applications completed by applicants applying to FDA’s fellowship programs. They allow the agency to efficiently review information from students and healthcare professionals who are
Drugs
Eighty-eight patient- and disease-focused organizations say they support FDA for recognizing the need for a central Office of Patient Affairs to coordinate opportunities for patient involvement in medical product development and regulation at the agency. While the groups say the new office will be essential to success of
Drugs
Two Shook, Hardy & Bacon attorneys say that a review of new Supreme Court justice Neil Gorsuch’s 10th Circuit Court of Appeals preemption appeals indicate that his appointment should help maintain the status quo as it relates to preemption jurisprudence. “More significantly,” they write in a Washington Legal Foundation
Drugs
FDA commissioner Scott Gottlieb says the agency will hold a 7/18 public meeting to solicit input on places where the agency’s rules, including the standards and procedures related to generic drug approvals, are being used in ways that may create obstacles to generic drug access instead of insuring
Drugs
Rep. Morgan Griffith (R-VA) has introduced the Preserving Patient Access to Compounded Medications Act of 2017 (H.R. 2871), that supporters say will improve access to compounded medicines. The measure addresses office-use compounding when authorized by state law and United States Pharmacopeia or National Formulary monograph requirements. It
Drugs
Sen. Charles Grassley (R-IA) says he and several colleagues have introduced the Creating and Restoring Access to Equivalent Samples (CREATES) Act (S. 974) to help FDA address REMS program abuse in which brand drug manufacturers restrict generic manufacturer access to samples for product testing and refuse to enter into
Drugs
FDA has approved a Shire NDA for Mydayis (mixed salts of a single-entity amphetamine product), a once-daily treatment comprising three different types of drug-releasing beads for patients 13 years and older with Attention Deficit Hyperactivity Disorder (ADHD). Approval was based on data from 16 clinical studies evaluating
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “FDA Rapid Response Surveys (Generic Collection) OMB Control Number 0910–0500.” The notice covers rapid response surveys for community based health care professionals, general type medical facilities, specialized medical facilities (those known for cardiac surgery, obstetrics/gynecology
Devices
Vascular Solutions has begun a recall of its Venture catheter because there is a risk of the catheter tip splitting or separating during use. “Excess material at the tip of the catheter may separate and could enter the patient’s bloodstream,” a recall notice says. “This can result in serious
Drugs
Members of the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 19-0 that the results of the LEADER trial establish that use of Novo Nordisk’s Victoza (liraglutide) in patients with Type 2 diabetes is not associated with excess cardiovascular risk. The 10/2016 sNDA requested inclusion of the
Drugs
An ongoing FDA/European Medicines Agency (EMA) pilot program on good clinical practice (GCP) inspections has shown promising results that could lead to greater harmonization and eventual mutual recognition of inspection reports, according to officials from the regulatory agencies. Speaking at a Drug Information Association session in Chicago 6/20,
Drugs
Critics say that aspects of a draft executive order on drug prices obtained by The New York Times would likely increase drug prices rather than bring any relief. One element in the draft targets the so-called 340B program that requires the drug industry to give discounts to hospitals and
Drugs
CDER has seen growing drug industry interest in its Emerging Technology Program, Center Office of Testing and Research director Lucinda Buhse told a Drug Information Association session in Chicago 6/20. She said CDER has accepted 32 industry requests to participate in the program over the past two years. She
FDA Policy/General
Federal Register notice: FDA has announced a 7/19 public workshop on scientific and clinical trial design considerations for developing new tuberculosis (TB) treatment regimens. Workshop discussions will focus on drug development programs and studies intended to evaluate shorter and better tolerated TB drug regimens and new regimens that have
FDA Policy/General
Federal Register notice: FDA is seeking comments on the information collection requirements in its “Guidance for Industry on Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act: OMB Control Number 0910–0777. A facility that compounds drugs may elect to register
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions.” The correspondence process was identified as part of the performance goals and program enhancements for the Generic Drug User Fee Amendments reauthorization for Fiscal Years 2018–2022. The guidance describes
Drugs
FDA has approved two Melinta Therapeutics NDAs for Baxdela (delafloxacin), indicated in adults for treating acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. The company describes Baxdela as a fluoroquinolone that exhibits activity against both gram-positive and gram-negative pathogens, including methicillin-resistant Staphylococcus aureus,
Drugs
FDA has issued Egalet Corp. a complete response letter on a prior approval supplement (PAS) for Oxaydo (oxycodone HCl, USP) tablets [Schedule C-II] in 10 mg and 15 mg dosage strengths. The agency letter requested more information about the effect of food on Oxaydo 15 mg and the intranasal