FDA Policy/General
The House Committee on Science, Space and Technology has opened an investigation into the dismissal of a researcher working under a fellowship at CBER, particularly allegations that the fellow was terminated in retaliation for his 2014 testimony before Congress during the Ebola crisis that may have cast the agency in
FDA Policy/General
DEVICES FDA Adds Device Patient Engagement Advisory Committee Federal Register Final rule: FDA is amending the standing advisory committees’ regulations to add the Patient Engagement Advisory Committee. Its function is to provide advice to the commissioner on complex issues relating to medical devices, the regulation of devices, and their use
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance: General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products. It recommends studies, including comparative in vitro studies, that should be conducted to demonstrate that a proposed generic solid oral opioid drug product is no less
FDA Policy/General
Federal Register Notice: FDA submits a proposed collection of information, “Environmental Impact Considerations,” to the Office of Management and Budget. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Guidance on Reagents for Detection of Specific Novel Influenza A Viruses — 21 CFR Part 866,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. FDA issued an order classifying
FDA Policy/General
Federal Register Notice: FDA is announcing that it has received a petition requesting exemption from the premarket notification requirements for a method, metallic reduction, glucose (urinary, non-quantitative) test system in a reagent tablet format that is intended to measure glucosuria (glucose in urine). These test systems in a are
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Alikay Naturals/Black Onyx World, LLC Fort Myers, FL (3/16). Unapproved new drug, misbranded: FDA laboratory analysis determined that “Bentonite Me Baby” contains lead at levels of 37.
FDA Policy/General
Federal Register Proposed rule: FDA has determined that powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices. FDA is confronted with an increasing number of premarket submissions that include an MR conditional labeling claim for multiconfiguration passive medical devices. The
FDA Policy/General
Federal Register Notice: FDA and the Parenteral Drug Association will co-sponsor a public conference 9/12-14 entitled: “Aligning Manufacturing Goals with Patient Needs through Successful Innovation and Compliance.” It will cover current issues affecting the industry as well as explore strategies to facilitate the development and continuous improvement
FDA Policy/General
FDA said 3/21 that its Center for Veterinary Medicine has approved Leawood, KS-based Aratana Therapeutics’ Galliprant (grapiprant tablets), indicated to control osteoarthritis pain and inflammation in dogs. An agency release said the drug is a new treatment option for dogs with this condition. It is a prostaglandin E2
FDA Policy/General
BIOLOGICS FDA has approved Bayer’s Kovaltry (antihemophilic factor-recombinant), a factor VIII compound for treating hemophilia A in children and adults. The approval is based on data from the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) clinical trials, which demonstrated the therapy’s supported
FDA Policy/General
BIOLOGICS Guidance on Biologics License Provisions Federal Register Notice: FDA is making available a draft guidance for industry entitled Implementation of the ‘Deemed to be a License’ Provision of the Biologics Price Competition and Innovation Act of 2009. It describes the agency’s approach to implementing the statutory provision under
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Quantitative Information in Direct-to-Consumer Television Advertisements,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA seeks comment on “Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans.” Comments should be submitted by 5/17. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is issuing an order under the Federal Food, Drug, and Cosmetic Act permanently debarring Wesley A. McQuerry from providing services in any capacity to a person that has an approved or pending drug product application. McQuerry was convicted of a felony under federal law for conduct
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications. In order to improve the process for submission and CMC information for animal drugs, CVM has developed a series of questions that
FDA Policy/General
FDA’s Office of New Drugs (OND) has granted a Fabre-Kramer Pharmaceuticals appeal through the agency’s formal dispute resolution process and has concluded that its Travivo (gepirone) demonstrates substantial evidence of effectiveness in treating major depressive disorder, thereby overturning the agency’s previous position reached at a lower
Drugs
A new ProPublica analysis finds that doctors who receive payments from industry tend to prescribe more brand-name medications than their colleagues who don’t. ProPublica says its analysis doesn’t prove industry payments sway doctors to prescribe particular drugs, or even a particular company’s drugs. “Rather, it shows
FDA Policy/General
Federal Register Notice: CBER and CDER are announcing the end of support for Version 1.0 of Clinical Data Interchange Standards Consortium Case Report Tabulation Data Definition Specification (Define.xml) and an update to the FDA Data Standards Catalog. Use of Define.xml Version 2.0, which has been available
FDA Policy/General
Federal Register Notice: FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet 5/25 from 8 a.m. to 5 p.m. at FDA White Oak Campus, Building 31 Conference Center, the Great Room (Rm. 1503), 10903 New Hampshire Ave., Silver Spring, MD. The committee will discuss the safety
FDA Policy/General
Federal Register Notice: FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet 6/7, from 8 a.m. to 4 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room