FDA Policy/General
Federal Register Notice: FDA is making available a guidance for industry entitled Safety Considerations for Product Design to Minimize Medication Errors. The guidance is intended for sponsors of investigational new drug applications; NDAs, BLAs, ANDAs; and manufacturers of prescription drugs marketed without an approved application or over-the-counter monograph
FDA Policy/General
Federal Register Notice: The Center for Veterinary Medicine (CVM) is proposing to withdraw approval of NADAs providing for use of carbadox in medicated swine feed. This action is based on CVM’s determination that the use of carbadox under the approved conditions of use results in residues of carcinogenic concern
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information “Medical Device User Fee Cover Sheet, Form FDA 3601,” 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’s proposed collection of information “Administrative Detention and Banned Medical Devices — 21 CFR 800.55(g)(1) and (g)(2), 800.55(k), 895.21(d), and 895.22,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork
FDA Policy/General
Federal Register Notice: FDA is publishing a list of information collections that have been approved by the Office of Management and Budget. These are: Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; Foreign Supplier Verification Programs for Importers of Food for Humans
FDA Policy/General
BIOLOGICS Guidance on Biosimilar Product Labeling Federal Register Notice: FDA is making available a draft guidance for industry entitled Labeling for Biosimilar Products. It is intended to assist applicants in developing draft prescription drug labeling for proposed biosimilar products and pertains only to the prescribing information (commonly referred to as
FDA Policy/General
CVM has begun an approval rescission action against Phibro Animal Health’s carbadox and its use in treating swine because the drug may leave trace amounts of a carcinogenic residue. The Center’s move comes after it recently reexamined the drug’s safety profile and conducted a preliminary risk characterization
FDA Policy/General
Federal Register Notice: FDA seeks comments on extending Office of Management and Budget approval on the existing reporting requirements related to submitting information electronically to the Center for Veterinary Medicine using the FDA Electronic Submissions Gateway. Comments should be submitted by 6/7. To view this notice, click here.
FDA Policy/General
Federal Register Notice: The FDA commissioner is renewing the Bone, Reproductive and Urologic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 3/23/18. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is amending the notice of a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to reflect a change in date to 5/25 from 8 a.m. to 5 p.m. This meeting was announced in the 3/16 Federal Register and is scheduled to
FDA Policy/General
The Senate Health, Education, Labor and Pensions (HELP) Committee has voted out five bills that completes the Senate’s work on companion legislation to the House’s 21st Century Cures Act that passed last year. What is missing is an agreement on mandatory funding for the National Institutes of Health.
FDA Policy/General
Federal Register Notice: FDA is amending a notice of a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee announced in the 3/17 Federal Register. The date of the meeting is changed to from 5/25 to 5/24. The committee will discuss the safety and efficacy of a
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Chaotic Labz, Line One Nutrition, Inc., m4 Nutrition Companies LLC, NutraClipse, Inc., Swagger Supps, Total Body Nutrition, Xcel Sports Nutrition, LLC (3/31). Misbranded: The firms offer products which
FDA Policy/General
Federal Register Notice: FDA is making available a final guidance entitled Comparability Protocols —Chemistry, Manufacturing, and Controls Information for New Animal Drugs. This document provides recommendations to applicants on preparing and using comparability protocols for postapproval changes in chemistry, manufacturing, and controls (CMC) information. It is intended to provide recommendations
FDA Policy/General
Federal Register Direct final rule: FDA is amending the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA’s IRB regulations. FDA is clarifying that it may require the IRB to withhold approval of new FDA-regulated
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Brintellix (vortioxetine hydrobromide) is 2,343 days for extending a patent that claims the human drug product. Brintellix is indicated for treating major depressive disorder. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that the agency will not begin procedures to withdraw approval of ANDAs that refer to these drug products, and it will allow
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Labeling for Biosimilar Products. It is intended to assist applicants in developing draft prescription drug labeling for proposed biosimilar products and pertains only to the prescribing information (commonly referred to as the package insert). To download this
FDA Policy/General
Federal Register Notice: FDA is making available “Modifications to the List of Recognized Standards, Recognition List Number: 041” containing modifications it is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication will assist manufacturers who elect to declare conformity with
FDA Policy/General
Federal Register Proposed rule: FDA is proposing to amend the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA’s IRB regulations. It is clarifying that FDA may require the IRB to withhold approval of new FDA-
FDA Policy/General
Former FDA chief counsel Sheldon Bradshaw and two other partners from Hunton & Williams have joined King & Spalding’s life sciences practice. Bradshaw left FDA in 2007 to join Hunton & Williams. He previously served as Department of Justice (DoJ) Office of Legal Counsel deputy assistant attorney general. Prior
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry and public health stakeholders entitled Emergency Use Authorization of Medical Products and Related Authorities. Its purpose is to explain FDA’s current thinking about policies on the authorization of the emergency use of certain medical products under certain