FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Elemental Impurities in Drug Products. It provides recommendations on the control of elemental impurities of human drug products marketed in the U.S. consistent with implementation of International Council for Harmonization (ICH) guidance for industry Q3D Elemental
FDA Policy/General
Waltham, Mass.-based Morphic Therapeutic says it has raised $51.5 million in a Series A venture financing to build on the shifting state of integrin receptors commonly found on the surface of about 90% of human cells from Tim Springer at Harvard Medical School. GlaxoSmithKline’s SR One venture
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Vulvovaginal Candidiasis: Developing Drugs for Treatment. Its purpose is to assist sponsors in the clinical development of drugs for treating uncomplicated vulvovaginal candidiasis. To download this guidance, click here. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is sponsoring a public workshop 10/24 and seeking public comment on Erythropoietic Protoporphyria (EPP). The workshop is intended to discuss how best to facilitate and expedite the development of safe and effective drug therapies to treat signs and symptoms related to EPP. FDA will provide
FDA Policy/General
Federal Register Proposed rule: FDA is proposing to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange system authorized by the U.S. Customs and Border Protection Agency (CBP), in order for the filing to
FDA Policy/General
BIOLOGICS AbbVie has received FDA approval for Humira (adalimumab) for treating non-infectious intermediate, posterior and panuveitis. DEVICES FDA has cleared Avitus Orthopaedics’ Avitus Bone Harvester device for gathering autologous bone graft and bone marrow. It allows physicians to gather autografts in a minimally invasive fashion, according to the company.
FDA Policy/General
BIOLOGICS Guidance on Biotherapeutic Products Clinical Trials Federal Register Notice: FDA is making available a guidance: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry. It provides investigational new drug application (IND) sponsors with recommendations on IND submissions for early clinical trials with live
FDA Policy/General
Federal Register Proposed rule: FDA is amending the 1994 tentative final monograph (TFM) or proposed rule for over-the-counter (OTC) antiseptic drug products. The agency is proposing to establish conditions under which OTC consumer antiseptic products intended for use without water (referred to throughout as consumer antiseptic rubs or
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for the public and FDA staff entitled Gifts to FDA: Evaluation and Acceptance. The secretary of the Department of Health and Human Services has the authority to accept conditional or unconditional gifts on behalf of the U.S. The secretary
FDA Policy/General
Federal Register Notice: FDA will hold a meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee 8/16, from 8 a.m. to 6 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD.
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 8/4 from 8 a.m. to 5 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
FDA Policy/General
Federal Register Final order: FDA is classifying the electrosurgical device for over-the-counter esthetic use into Class 2 (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the electrosurgical device for over-the-
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees; Guidance for the Public, FDA Advisory Committee Members, and FDA Staff. It addresses FDA's process, under government-wide federal regulations, for evaluating whether
Drugs
While CDER’s Office of Prescription Drug Promotion (OPDP) has been relatively quiet in its issuance of Warning and untitled letters the past two years, it appears staffers are probably keeping busy with an increased workload in advertising/promotion (Form 2253) submissions. Last year, OPDP received a total of 96,
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Coastal Meds, LLC Biloxi, MS (6/22). Inspected 9/15-23/15. CGMP deviations, adulterated, misbranded, unapproved new drug products: The FDA investigator observed serious deficiencies in the firm’
FDA Policy/General
A panel of six former FDA commissioners, who combined have 32 years of FDA leadership experience, told an Aspen Institute/Atlantic magazine conference 6/25 they strongly believe the agency should be independent and not housed under Health and Human Services, and that it should operate under a model used
FDA Policy/General
Federal Register Notice: FDA is extending the comment period for a 5/4 notice of availability of the draft guidance for industry entitled Special Protocol Assessment. FDA is taking this action due to maintenance on the Federal eRulemaking portal from 7/1-7/5. Comments should be submitted by 7/
FDA Policy/General
Federal Register Notice: FDA is making available a Technical Specifications Document entitled “Quality Metrics Technical Conformance Guide, Version 1.0.” It provides technical recommendations for the submission of quality metric data. It serves as the technical reference for implementation of the draft FDA guidance for industry when finalized, Request for
FDA Policy/General
Federal Register Notice: FDA is making available a publication containing modifications it is making to the list of standards that the agency recognizes for use in premarket device reviews. This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 043,” will assist manufacturers who elect to declare
FDA Policy/General
Federal Register Notice: FDA is extending the comment period for a 5/4 notice of availability of the draft guidance for industry entitled Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment. FDA is taking this action due to maintenance on the Federal eRulemaking portal from 7/
FDA Policy/General
A new report by OpenTheBooks.com examines the purchases of weapons federal agencies, including FDA. “Regulatory enforcement within administrative agencies now carries the might of military-style equipment and weapons, according to the report, The Militarization of America: Non-Military Federal Agencies Purchases of Guns, Ammo, and Military-Style Equipment.
FDA Policy/General
BIOLOGICS FDA Withdraws Notice on Biological Product Naming Federal Register Withdrawal of notice: FDA withdraws a 6/2 Federal Register notice, which announced that a proposed collection of information, “Guidance for Industry on Nonproprietary Naming of Biological Products,” had been submitted to the Office of Management and Budget. To view