FDA Policy/General
FDA watchers are calling President Trump’s budget blueprint, which includes a doubling of user fees (see story), “dead on arrival,” according to an Alliance for a Stronger FDA analysis. During a 3/22 hearing, lawmakers expressed concern of the blueprint’s discussion on increasing user fees. “This Congressional reaction
Drugs
A study in the Journal of the American Medical Association says that there is a correlation between increases in the number of men seeking and taking testosterone and televised direct-to-consumer ads for the drug. An online CardioBrief post says that although testosterone is approved only for men with
FDA Policy/General
Federal Register notice: CDRH has announced its 2017 Experiential Learning Program, a training component that is intended to provide Center staff with an opportunity to understand the policies, laboratory practices, patient perspective/input, quality system management, and other challenges that impact the device development life cycle. CDRH is inviting medical
FDA Policy/General
Pharmaceutical Research and Manufacturers of America (PhRMA) says two proposed FDA studies on consumer and healthcare professional identification of false or misleading drug promotion appear to offer little practical usefulness. The association’s comment letter says that identifying deceptive promotion is FDA’s assigned responsibility and not the duty of
FDA Policy/General
Federal Register notice: FDA has announced a two-day (4/4-5) public conference entitled “FDA CDER Small Business and Industry Assistance (SBIA) Regulatory Education for Industry (REdI) Generic Drugs Forum.” The conference is intended to provide information on the key aspects of the generic drug development process. It will
FDA Policy/General
Federal Register Notice: FDA is seeking comments on an information collection extension for “Annual Reporting for Custom Device Exemption.” Custom devices are those created or modified in order to comply with an order from an individual physician or dentist. The notice covers annual reporting requirements by manufacturers to FDA about
FDA Policy/General
Federal Register Notice: FDA has delayed until 3/19/2018 the effective date of its final rule on “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses,’” which published on 1/9. FDA has received a
FDA Policy/General
Federal Register notice: FDA has corrected a 12/29/2016 notice about a public workshop entitled “Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products.” The notice corrects an error in the Web site address to access the workshop transcript when
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Medical Devices; Reports of Corrections and Removals — 21 CFR Part 806.” The information collection requires reporting within 10 working days of initiating any action to correct or remove a device that poses a health risk or to
FDA Policy/General
FDA acting commissioner Stephen Ostroff 3/20 announced the appointment of longtime Republican operative Jack Kalavritinos to be the agency’s new associate commissioner for external affairs, responsible for FDA communications to the media, Congress, and the general public, effective immediately. In an email to FDA senior staff, Ostroff said
FDA Policy/General
Draft Guide on Generic Rifaximin Bioequivalence 03/17/2017 Federal Register notice: FDA makes available a revised draft guidance for industry on generic rifaximin oral tablets and bioequivalence issues. FDA Eliminates Regional Director Positions 03/17/2017 Federal Register final rule technical amendment: FDA makes revisions to Chapter I of
FDA Policy/General
Federal Register Notice: FDA is seeking comments on an information collection extension for its “Guidance for Industry on Pharmacogenomic Data Submissions.” The document provides recommendations to sponsors on what pharmacogenomic data should be submitted to the agency during the drug development process. To view the notice, click here.
FDA Policy/General
Federal Register Notice: FDA is seeking comments on an information collection reinstatement for “Premarket Notification—21 CFR Part 807, Subpart E. The information collection involves Form FDA 3514, a summary cover sheet form, that is intended to assist respondents in categorizing administrative 510(k) information for submission to FDA. This
FDA Policy/General
Federal Register Notice: FDA is seeking comments on an information collection extension for its guidance on “Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act.” The document recommends that applicants who submit certain medical device applications include, if readily available,
FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance for industry on generic rifaximin oral tablets and bioequivalence issues. The “Draft Guidance on Rifaximin” is intended to provide product-specific recommendations on, among other things, the design of bioequivalence studies to support ANDAs for rifaximin oral tablets. To
FDA Policy/General
Federal Register final rule technical amendment: FDA has made revisions to Chapter I of its regulations to eliminate the position of regional food and drug director. The revisions replace references to the regional food and drug director, who is designated to preside over administrative appeals and at informal hearings on
FDA Policy/General
Federal Register notice: FDA has corrected a 12/15/2016 notice entitled “Public Meeting on Patient-Focused Drug Development for Sarcopenia” to reflect a change in meeting location. The new location is Tommy Douglas Conference Center, 10903 New Hampshire Ave., Building 51, Room. 1146, Silver Spring, MD 20993. To view
FDA Policy/General
President Trump’s just-released fiscal year 2018 budget blueprint is meeting significant resistance from FDA constituencies over a proposed doubling of FDA user fees on regulated industry’s medical product marketing applications, to about $2 billion annually. Such a jump “replaces the need for new budget authority to cover
FDA Policy/General
FDA will publish in the 3/17 Federal Register a notice revising Chapter I of its regulations to reflect changes to the agency’s organizational structure, including dissolution of the Regional Food and Drug Director position. The notice says the revisions replace references to the Regional Food and Drug Director,
FDA Policy/General
Federal Register notice: FDA has determined that cyanocobalamin injection, 1 milligram per milliliter in a 10 milliliter vial, was not withdrawn for reasons related to safety or effectiveness. This determination means that the agency will continue to approve ANDAs that refer to the product as long as they meet relevant
FDA Policy/General
The Government Accountability Office (GAO) says that since its 2011 report, FDA and the Agriculture Department have made progress in overseeing use of medically important drugs in food animals, but still more needs to be done. The agency’s report says that since 2011, FDA has increased veterinary oversight of
FDA Policy/General
Federal Register Notice: FDA has extended the comment period for a 1/18 notice regarding a guidance on “Considerations in Demonstrating Interchangeability with a Reference Product.” The document is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes