FDA Policy/General
Federal Register Notice: FDA is seeking comments on abuse potential, actual abuse, medical usefulness, trafficking, and impact of controlled substance scheduling changes on availability for medical use of 12 drug substances. The comments will be considered in preparing a response from the U.S. to the World Health Organization (W.
FDA Policy/General
Federal Register Notice: FDA has established a docket to receive suggestions, recommendations, and comments on a list of biomarkers that were used as outcomes to develop FDA-approved new molecular entities and biological therapeutics from 2007 to 2015. Comments received on the list will help FDA determine the utility of
FDA Policy/General
Federal Register Notice: FDA is publishing a notice that an applicant for a proposed biosimilar product notified the agency that a patent infringement action was filed in connection with the applicant’s biologics license application. Under the Public Health Service Act, a biosimilar applicant must notify FDA within 30 days
FDA Policy/General
Federal Register Notice: FDA is seeking public comments on a proposed collection of certain information to support social and behavioral research used by the agency about drug products. The agency is interested in obtaining data to understand patients, consumers and health care professionals’ perceptions and behaviors in order to improve
FDA Policy/General
Federal Register notice: FDA is posting a draft guidance entitled “S9 Nonclinical Evaluation for Anticancer Pharmaceuticals—Questions and Answers” that provides recommendations for nonclinical studies for the development of pharmaceuticals intended to treat patients with cancer. To view this guidance, click here. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA has announced a public meeting entitled “Health Canada and FDA Joint Public Consultation on International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The meeting will provide information and receive comments on the current activities of ICH, as well as the upcoming
FDA Policy/General
Federal Register Notice. FDA is announcing a public meeting to discuss proposed recommendations for reauthorizing the Biosimilar User Fee Act (BsUFA) for fiscal years 2018 through 2022. FDA will consider the public views and comments from this meeting to revise the recommendations as necessary. The public meeting will be held
FDA Policy/General
Federal Register Notice: FDA is announcing a public meeting entitled “Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act.” The meeting is intended to provide members of the pharmaceutical distribution supply chain and other stakeholders an opportunity to share information with the agency about the
FDA Policy/General
ANIMAL DRUGS Guidance on Animal Drug Bioequivalence Waivers Federal Register Notice: FDA has made available a revised guidance for industry (#171) on “Waivers from the Requirement to Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles.” The document describes how CVM intends
FDA Policy/General
Federal Register Notice: FDA is seeking comments on a proposed collection of information related to the agency’s Unique Device Identification (UDI) System. Comments are sought on requirements for medical device labelers to include an expiration date, a date of manufacture, or any other date intended to be brought to
FDA Policy/General
Federal Register Notice: FDA is making available a guidance on “Qualification of Biomarker — Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease.” The document provides a qualified context of use for total kidney volume, measured at baseline, to be used as a prognostic enrichment biomarker to
FDA Policy/General
Federal Register Notice: FDA has released a guidance on “Recommendations for Microbial Vectors Used for Gene Therapy” that provides recommendations concerning IND submissions for microbial vectors used for gene therapy in early phase clinical trials. The guidance focuses on the chemistry, manufacturing, and control information that sponsors should submit in
FDA Policy/General
Federal Register Notice: FDA has made available a revised guidance for industry (#171) on “Waivers from the Requirement to Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles.” The document describes how CVM intends to evaluate requests for waiving the requirement for
FDA Policy/General
Federal Register Notice: FDA has planned a public workshop on “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices (ASTs). It is intended to facilitate discussion between drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs or ASTs and who wish to coordinate development of
FDA Policy/General
Federal Register Notice: FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation have planned a three-day (11/7-9) training course for clinical investigators. It is intended to provide expertise in the design, conduct, and analysis of clinical trials; to improve the quality of
FDA Policy/General
Drug company digital and non-personal contacts are on the rise as sales representatives are denied access to physicians, according to new reports from ZA Associates. In fact, such activities have now exceeded the number of sales rep visits to doctor offices, the reports say. According to AccessMonitor, the number
FDA Policy/General
Brown University researchers say that while little has been learned over the years about the effect of direct-to-consumer advertising on psychiatric conditions, it appears that the ads succeed in driving prescribing with potentially mixed effects on patient care. Writing in the Journal of Clinical Psychiatry, the researchers say
FDA Policy/General
Federal Register Notice: FDA has canceled an 11/16-planned meeting of the Vaccines and Related Biological Products Advisory Committee that was scheduled to review a hepatitis B vaccine manufactured by Dynavax. FDA says the cancelation will allow time for the agency to review and resolve several outstanding issues. A
FDA Policy/General
Federal Register Notice: FDA is withdrawing approval for parts of a new animal drug application (NADA) for a three-way, fixed-ratio, combination drug Type A medicated article that pertains to use of the procaine penicillin component for production indications in swine. The withdrawal is being taken at the sponsor’
FDA Policy/General
Continuing its investigation into the FDA Office of Criminal Investigations (OCI), Reuters says that OCI agents routinely share details about criminal matters pending before grand juries with more than two dozen top agency officials. The news service says the “headquarters alerts” let the executives know about expected actions inside or
FDA Policy/General
Federal Register Notice: FDA is seeking comments on establishing appropriately targeted durations of use for antimicrobial drugs which are important for human use, when they are administered in the feed or water of food-producing animals for therapeutic purposes. The request for comments is part of the government’s National
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) says that Web sites operated by Durect Corp. and Pain Therapeutics Inc. are promoting Remoxy ER (oxycodone) extended-release capsules, an investigational new drug, as being safe and effective for the purposes for which it is being investigated. A 9/8 Notice