FDA Policy/General
Federal Register notice: Responding to a citizen petition request, FDA has determined that Wyeth Pharmaceuticals’ Cordarone (amiodarone hydrochloride) tablets, 200 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination means that the agency can approve ANDAs that refer to the product as long as they
FDA Policy/General
Federal Register notice: FDA has a announced a 9/14 joint meeting of its Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee. Panel member are scheduled to review a Purdue Pharma supplemental NDA new for Butrans (buprenorphine) transdermal system for use in pediatric
FDA Policy/General
Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports substantive research focused on prescription drug advertising and promotion, but is concerned with FDA’s recent approaches to studies in this area. In a letter commenting on an agency proposal to study disclosures in professional and consumer prescription drug promotion,
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Foshan Flying Medical Products Co. Foshan City, China (8/1): FDA inspected the firm in February and cited significant GMP violations with its finished pharmaceuticals. For example, the firm
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed method for applying a food animal biomass denominator to annual data on antimicrobials sold and distributed for use in food animals in the U.S. The method will allow the agency to obtain a corrected estimate of antimicrobial drug sales
FDA Policy/General
A new policy on security background checks is raising confusion and alarm for some FDA scientists, according to an online Science post. The article says the change was included in a “communications plan” that went to agency senior staff in recent weeks. Science says the plan “appears to effectively bar
FDA Policy/General
Federal Register notice: FDA is requesting comments about abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 17 drug substances. The comments will be considered in preparing a response from the U.S. to the World Health Organization (WHO) regarding abuse
FDA Policy/General
FDA’s Center for Veterinary Medicine is proposing to use a “biomass indicator” to help it better analyze antimicrobial sales and food-animal population data it already receives. According to an 8/14 CVM Update, a biomass denominator is the population of a given livestock population in the U.S.
FDA Policy/General
Federal Register notice: FDA has announced the availability of a guidance on “Qualification of Medical Device Development Tools (MDDT)” that is intended to finalize the MDDT program. The document also discusses the framework of an MDDT, including definitions of applicable terms, criteria for evaluating an MDDT for a specific context
FDA Policy/General
The General Services Administration (GSA) says it will prepare an environmental impact statement (EIS) for a proposed master plan to support a significant staff increase at FDA’s White Oak headquarters. An 8/11 Federal Register notice says that a 1997 EIS analyzed the impacts from consolidation of 5,975
FDA Policy/General
Federal Register notice: FDA has announced the availability of a revised draft guidance on “Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.” The document describes the conditions under which FDA does not intend to take action regarding required stability studies for these repackaged products and instructs
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports.” The document provides recommendations to BLA holders, describing chemistry, manufacturing, and controls postapproval manufacturing changes that the agency generally considers to have a minimal potential
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Cellex-C International Toronto, Canada (8/2): FDA inspected the firm in January and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to have, for
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its “Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics.” The document provides information concerning cooperative manufacturing arrangements applicable to biological products subject to licensure under section 351 of the Public Health Service Act. It addresses several
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection for “Prescription Drug Advertisements.”The agency’s drug advertising regulations describe requirements and standards for print and broadcast advertisements. Advertisements that are broadcast through media such as television, radio, or telephone communications systems must disclose the major risks from
FDA Policy/General
Federal Register notice: FDA has announced the the availability of 48 final product-specific guidances that recommend the design of bioequivalence studies to support ANDAs. To view the guidances, visit here. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 9/19 Oncologic Drugs Advisory Committee meeting from 8:30am to 1pm. Panel members will review a C.P. Pharmaceuticals, represented by Pfizer, supplemental NDA for Sutent (sunitinib malate) oral capsules, indicated for the adjuvant treatment of adult patients at high risk of
FDA Policy/General
Federal Register notice: FDA has announced a 9/13 Vaccines and Related Biological Products Advisory Committee meeting. The panel will review the safety and effectiveness of GlaxoSmithKline Biologicals’ zoster vaccine recombinant. To view the notice, click here.
FDA Policy/General
Guide on Child-Resistant Packaging Statements Federal Register notice: FDA announces the availability of a draft guidance on “Child-Resistant Packaging Statements in Drug Product Labeling.” 08/03/2017 FDA Withdraws Approval for 4 B. Braun Medical Drugs Federal Register notice: FDA announces that it is withdrawing approval of three
FDA Policy/General
Medical product user fees account for 38% of FDA’s funding, but when you add tobacco user fees, which fund 100% of the agency’s tobacco-related programs, they raise the overall user fee percentage to 47%. The tobacco fees skew the budget numbers and may detract from legitimate budget
FDA Policy/General
Federal Register notice: FDA has announced the availability of a draft guidance on “Child-Resistant Packaging Statements in Drug Product Labeling.” The document is intended to assist applicants, manufacturers, packagers, and distributors who choose to include child-resistant packaging (CRP) statements in prescription and over-the- counter human drug product
FDA Policy/General
Federal Register notice: FDA has announced that it is withdrawing approval of three NDAs and one ANDA held by B. Braun Medical. The company notified the agency that the products are no longer marketed and requested that the approval of the applications be withdrawn. Affected products include Dextran 70 (6%