FDA Policy/General
FDA Office of Criminal Investigations (OCI) director George Karavetsos has resigned and his last day is 1/20, the day president-elect Donald Trump is sworn into office. Karavetsos, who has a law degree, reportedly is joining a private law firm. Karavetsos’ resignation comes amid Capitol Hill criticism and an
FDA Policy/General
Federal Register Notice: FDA has made available draft guidance #242 entitled “In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products.” The document discusses in-use stability testing, which is to establish a period of time during which a multiple-dose drug product may be
FDA Policy/General
(Analysis by Jim Dickinson) When President-elect Donald Trump turns his attention to FDA, he’ll likely face his comeuppance. As guardian of one-quarter of the Gross National Product, FDA is the agency closest to the daily wellbeing of the entire U.S. population (and indirectly to that of
FDA Policy/General
An FDA annual report summarizing sales and distribution data for all antimicrobial drugs approved for use in food-producing animals shows that sales and distribution of all antimicrobials increased 1% from 2014 through 2015, tied for the lowest annual increase since 2009. The report says that the percentage of the
FDA Policy/General
FDA needs to revamp its advisory committee process because the agency often stacks the deck with experts that will vote to support its review findings, according to a 12/30 Wall Street Journal opinion piece entitled “The FDA’s Rigged Drug Committees.” The article calls on the incoming Trump Administration
FDA Policy/General
FDA is soliciting comments on proposed research to determine how well consumers and healthcare professionals can identify and respond to deceptive prescription drug promotion. A Federal Register notice says that while studies have looked at the occurrence and influence of deceptive promotion, none have looked at the ability of consumers
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says that a Zydus Discovery DMCC YouTube video on Lipaglyn (saroglitazar) tablets suggests in a promotional context that the investigational new drug is safe and effective for the purposes for which it is being investigated or otherwise promotes the drug. A 12/
FDA Policy/General
FDA Webview posts the Federal Register summaries for notices released during our holiday break (12/19 to 12/30). ANIMAL DRUGS Guide on Question-based Reviews for Animal Drugs Federal Register Notice: FDA has issued a guidance #234 entitled “Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section
FDA Policy/General
A Chiasma YouTube video is promoting the investigational new drug octreotide, including using its proprietary name Mycapssa, according to a 12/21 Notice of Violation issued by the CDER Office of Prescription Drug Promotion to the company. The OPDP letter cites a 4/18/16 Chiasma press release reporting on
FDA Policy/General
Federal Register Notice: FDA has made available a draft guidance on “Premarket Notification (510(k)) Submissions for Bone Anchors.” The document provides recommendations for the information and testing that should be included in premarket submissions for bone anchor(suture anchor) devices used in the appendicular skeleton for attachment of soft
FDA Policy/General
Federal Register Notice: FDA has made available a guidance entitled “Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” The document addresses new provisions added by the Drug Quality and Security Act and updates reporting instructions for drug
FDA Policy/General
In an interview with the Washington Post as he prepares to return to Duke University, from which he is on leave, FDA commissioner Robert Califf says that for FDA to be able to make scientifically sound decisions, it needs more evidence about a regulated product’s safety and efficacy. He
FDA Policy/General
Federal Register Notice: FDA has made available a guidance on “Gifts to FDA: Evaluation and Acceptance.” The HHS secretary has the authority to accept conditional or unconditional gifts on behalf of the U.S., and this authority has been delegated to the FDA commissioner. The document provides the process and
FDA Policy/General
Federal Register Notice: FDA is seeking comments on an information collection related to “Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer from a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure— 21 CFR Part 814.” The agency’
FDA Policy/General
Federal Register Notice: FDA has made available a guidance entitled “Bioequivalence: Blood Level Bioequivalence Study.” The document is intended to harmonize the data recommendations associated with in vivo blood level bioequivalence for veterinary pharmaceutical products. To view the notice, click here.
FDA Policy/General
Federal Register Notice: FDA has made available a guidance on “Gifts to FDA: Evaluation and Acceptance.” The HHS secretary has the authority to accept conditional or unconditional gifts on behalf of the U.S., and this authority has been delegated to the FDA commissioner. The document provides the process and
FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) says that a Web page for Spriaso’s Tuxarin ER (codeine phosphate and chlorpheniramine maleate) extended release tablets makes false or misleading claims or representations about risks associated with the drug and inadequately communicates its full indication. “This Web page is concerning
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says that a professional e-mail for United-Guardian’s Renacidin (citric acid, glucono, delta-lactone, and magnesium carbonate) irrigation solution makes false or misleading claims or representations about the product’s risks and benefits, misbranding it. A 12/13 Warning Letter
FDA Policy/General
FDA 12/15 announced the appointment of deputy associate commissioner for regulatory affairs Steven M. Solomon, DVM, as the new leader of the agency’s Center for Veterinary Medicine (CVM). He will assume the position next month from acting director Tracey Forfa, JD. who is currently serving as the Acting
FDA Policy/General
Federal Register Notice: FDA and HHS’s Office for Human Research Protections are making available a guidance entitled “Use of Electronic Informed Consent — Questions and Answers.” The document provides recommendations on the use of electronic systems and processes that may employ multiple electronic media to obtain informed consent for both
FDA Policy/General
Federal Register Notice: FDA is seeking comments on an information collection related to “Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act — OMB Control Number 0910–0375.” A third party wishing to participate is required to submit a request for accreditation to the agency. Accredited third-
FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) says that a direct-to-consumer TV ad for Sanofi-Aventis’ Toujeo (insulin glargine injection) U-300, for subcutaneous use, makes false or misleading representations about the risks associated with the drug. A 12/12 Notice of Violation says the violation “is