Devices
An FDA 2/18 final order says that manufacturers will have to submit a PMA application for two types of metal-on-metal (MoM) total hip replacement devices. Affected are the hip joint metal/metal semi-constrained with a cemented acetabular component, and the hip joint metal/metal semi-constrained
Drugs
Amarin says that it, FDA, and other parties have jointly requested a stay in court proceedings for the First Amendment litigation about commercial speech involving the company’s Vascepa. An 8/7/15 preliminary order confirmed the company’s right to engage in truthful and non-misleading speech promoting off-
Devices
Rep. Mike Fitzpatrick (R-PA) has asked CDRH director Jeff Shuren to review a new report identifying 303 fetal deaths allegedly associated with Bayer Health’s controversial Essure permanent birth control device. The congressman says that CDRH’s previous public materials related to Essure have cited five reports of fetal
Devices
CDRH has objected to plans for Sure Genomics to market its SureDNA test to consumers. The test, according to the company’s Web site, is intended to collect saliva samples and perform DNA sequencing and reporting of patient information, such as disease risks and likelihood of drug reactions. In a
Biologics
CBER director Peter Marks says that the Center’s Laboratory Quality System (LQS) program is an international leader in biological product regulation based on demonstrated expertise in laboratory techniques. Writing in an FDA Voice blog post, Marks says the LQS “is the coordinated structure, procedures, processes, and resources that the
Drugs
A 2/12-2/23/15 FDA inspection at Tri-Med, Inc., (doing business as Advanced Care Infusion-Shelby), Shelby Twp., MI, found “serious deficiencies” in the firm’s practices for producing sterile drugs, according to a just-released 12/18/15 Warning Letter from the agency’s Detroit District
Drugs
FDA has issued a guidance, Completeness Assessments for Type II API D MFs Under GDUFA, to make suggestions about information to be included in a drug master file (DMF) to facilitate a GDUFA completeness assessment. The document says it is intended for holders of Type 2 active pharmaceutical ingredient (API)
Drugs
Pfizer says its Wyeth subsidiary has reached an agreement to pay $785 million to resolve claims alleging that the company’s practices relating to the calculation of Medicaid rebates for its drug Protonix (pantoprazole sodium) between 2001 and 2006 violated the False Claims Act and other laws. When finalized, the
Drugs
Pharmaceutical and Research Manufacturers of America (PhRMA) is urging FDA to slow down on its initiative to use quality metrics as part of its risk-based inspection paradigm. In the first of what it says will be a series of blog posts on the topic, PhRMA says it “strongly recommends”
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance: Allergic Rhinitis: Developing Drug Products for Treatment. Its purpose is to assist sponsors in the development of drug products for treating seasonal allergic rhinitis and perennial allergic rhinitis. It revises the draft guidance for industry entitled Allergic Rhinitis: Clinical Development
FDA Policy/General
Federal Register Notice: FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation will hold a public workshop 3/24 entitled “Building the National Evaluation System for Medical Devices: Using Real-World Evidence to Improve Device Safety and Effectiveness.” Its objective is to discuss the scientific
FDA Policy/General
Federal Register Notice: FDA will hold a public workshop 4/5 entitled “Proposed Pilot Project(s) under the Drug Supply Chain Security Act (DSCSA).” It will provide a forum for discussing proposed design objectives of pilot projects that will explore and evaluate methods to enhance the safety and security of
FDA Policy/General
Federal Register Notice: FDA’s Oncologic Drugs Advisory Committee will meet 4/12 from 8:30 a.m. to 1 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss a Clovis
FDA Policy/General
Federal Register Notice: FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify the agency in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve
Devices
The Medical Alley Association, which advocates for Minnesota healthcare industry companies and individuals, says that 510(k) clearances declined 26% in 2015 to their lowest point in five years. At the same time, it says, comparable clearances outside the U.S. rose 51%. The group’s annual approval report also
Drugs
FDA has issued a complete response letter for a Merck sNDAs for Zetia and Vytorin to reduce the risk of cardiovascular events in patients with coronary heart disease. The company says the applications were based on results of IMPROVE-IT (Improved Reduction of Outcomes Vytorin Efficacy International Trial). It says
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry on cyclosporine ophthalmic emulsion entitled Draft Guidance on Cyclosporine. The recommendations provide specific guidance on the design of bioequivalence studies to support ANDAs for cyclosporine ophthalmic emulsion. To download this guidance, click here. To view this notice, click
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Nonallergic Rhinitis: Developing Drug Products for Treatment. The purpose of this draft guidance is to assist applicants in the development of drug and biological products for treating nonallergic rhinitis. To download this guidance, click here. To view
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax. Its purpose is to assist sponsors in the development of new drugs for this indication. This draft guidance supersedes the draft guidance entitled Inhalational Anthrax (Post-Exposure) — Developing Antimicrobial
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled Completeness Assessments for Type II API DMFs Under GDUFA. It finalizes the draft guidance entitled Initial Completeness Assessments for Type II API DMFs Under GDUFA, which published 10/2/12. This guidance is intended for holders of Type II active
FDA Policy/General
Federal Register Notice: FDA will hold a public workshop 3/9-10 entitled “Educational Conference Co-Sponsored with the Society of Clinical Research Associates (SOCRA).” The workshop on FDA’s clinical trial requirements is designed to aid the Clinical Research Professional’s understanding of the mission, responsibilities, and authority of
FDA Policy/General
Federal Register Notice: FDA is planning a public workshop 4/27-28 entitled “Evaluation of the Safety of Drugs and Biological Products Used During Lactation.” Attendees will discuss the current state and future directions of the collection of data on the potential risks to breastfed infants with maternal use of