FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Banner Pharmacy Services, LLC Phoenix, AZ (5/5). Inspected Chandler, AZ facility 3/16/15-3/2015. Violations, adulterated, misbranded, unapproved new drugs: The investigators noted that the facility
FDA Policy/General
Federal Register Proposed rule: FDA is extending the comment period for a 4/25 proposed rule in which the agency requested comments for a ban on electrical stimulation devices used for self-injurious or aggressive behavior. Comments should be submitted by 7/25. To view this notice, click here.
FDA Policy/General
DEVICES FDA has cleared a Bone Index 510(k) for the Bindex point-of-care instrument, which is intended to help in osteoporosis diagnosis. The device measures the cortical bone thickness of the tibia and its algorithm calculates a density index, a parameter which estimates bone mineral density at the
FDA Policy/General
BIOLOGICS FDA Renews Blood Panel Federal Register Notice: The FDA has renewed the charter of the Blood Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/13/18. To view this notice, click here. Blood Products Panel
FDA Policy/General
Federal Register Notice: FDA has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2015. These are CBER’s Blood Products Advisory Committee, National Center for Toxicological Research’s Science Board to the National Center for Toxicological Research,
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment. It is intended to assist sponsors in designing a clinical development program for new drug products for treating chronic obstructive pulmonary disease. This document revises the draft guidance of
FDA Policy/General
Federal Register Notice: FDA is publishing a list of 14 premarket approval applications that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency’s Division of Dockets Management. These PMAs include
FDA Policy/General
Federal Register Notice: FDA plans a meeting of the Blood Products Advisory Committee 6/20 from 9:30 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 members will
FDA Policy/General
Federal Register Notice: CDER is sponsoring a public workshop 8/29 entitled “Diabetes Outcome Measures Beyond Hemoglobin A1c (HbA1c).” Its purpose is to have a forum for dialog with the public, patients, patient advocacy groups and industry to gain greater appreciation on the extent to which the current regulatory paradigm
FDA Policy/General
Federal Register Notice: The FDA commissioner has renewed the Drug Safety and Risk Management Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/31/18. To view this notice, click here.
FDA Policy/General
Federal Register Notice: The FDA has renewed the Peripheral and Central Nervous System Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 6/4/18. To view this notice, click here.
FDA Policy/General
Reps. Fred Upton (R-MI), chairman of the House Committee on Energy and Commerce, and Tim Murphy (R-PA), chairman of the committee’s Subcommittee on Oversight and Investigations, say that FDA is lagging behind other agencies in taking staffing and budgeting steps to address laboratory safety and security. In
FDA Policy/General
Three FDA officials — chief health information officer Taha Kass-Hout, CDRH Office of In Vitro Diagnostics and Radiological Health associate director Zivana Tezak, and precisionFDA project manager Elaine Johanson — say that winners of the first precisionFDA challenge will be announced by commissioner Robert Califf 5/25. The challenge drew 21
FDA Policy/General
Federal Register Notice: The FDA has renewed the charter of the Blood Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/13/18. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA will hold a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee 6/28, from 8 a.m. to 5 p.m., at Hilton Washington DC/Rockville Hotel & Executive Meeting Center, Plaza Ballroom, 1750 Rockville Pike, Rockville, MD. The committee will discuss two Boehringer Ingelheim
FDA Policy/General
NIH has issued four new grants to support research on the ethical, legal and social questions raised by advances in genomics research and the increasing availability of genomic information. “The projects will examine the use of genomic information in the prevention and treatment of infectious diseases; genomic information privacy; communication
FDA Policy/General
A Senate Appropriations subcommittee has approved a 2017 funding bill that would provide FDA $2.8 billion in discretionary spending, a $39 million (1%) increase over fiscal year 2016 spending levels. Including revenue from user fees, total 2017 funding is $4.78 billion, which is $103 million above FY2016. Within
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Use of Electronic Health Record Data in Clinical Investigations. It is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards, and other interested parties on the use of electronic health record data in FDA-
FDA Policy/General
FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Eclipse Aesthetics, LLC. Farmers Branch, TX (3/28). Inspected 8/5-13/15. Adulterated, misbranded: The firm does not have an approved PMA or IDE application. Also, the firm did
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act. It is intended to assist manufacturers of devices subject to Section 522 postmarket surveillance orders by providing an overview of the Federal Food, Drug, and Cosmetic Act,
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements,” 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 is making available a guidance for industry entitled Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification. It is intended to assist submitters of a biomarker for qualification that conduct nonclinical biomarker qualification studies in which histopathology is used as a reference