FDA Policy/General
Federal Register notice: FDA is sending to OMB an information collection extension request for “Data To Support Drug Product Communications as Used by FDA: OMB Control Number 0910-0695.” The information collection is used to form opinions on a specific topic and as a qualitative research tool for two major
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Refuse to File: NDA and BLA Submissions to CDER” that is intended to clarify certain circumstances under which the Center may refuse to file an application. It also addresses the importance of submitting a complete application to minimize any
FDA Policy/General
Federal Register notice: FDA has established a “Susceptibility Test Interpretive Criteria Web site” that is intended to help efficiently update such criteria for antimicrobial drugs when necessary for public health and to allow for more efficient development and evaluation of antimicrobial susceptibility test devices. The Web site was mandated by
FDA Policy/General
The Medical Information Working Group (MIWG) says that while in some cases it is appropriate for FDA to eliminate existing regulations, such as where they lack clarity or are inconsistent with current policy reflected in guidance documents, it also believes that, in some areas, regulatory burdens are alleviated when agencies
FDA Policy/General
Federal Register notice: FDA has determined that Merck’s Noroxin (norfloxacin) tablets, 400 mg, was not withdrawn due to safety or effectiveness concerns. The determination will allow FDA to approve ANDAs citing the reference product if all other legal and regulatory requirements are met. Noroxin is indicated for treating adults
FDA Policy/General
FDA has asked the Office of Management and Budget to clear two studies to determine the ability of consumers and healthcare professionals to detect and report deceptive presentations in prescription drug promotion. The studies will focus on two different health conditions. CDER’s Office of Prescription Drug Promotion says that
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Orphan Products Development; FDA Orphan Drug Designation Request Form and The Common European Medicines Agency/FDA Form for Orphan Medicinal Product Designation (Formerly Orphan Drugs; Common European Medicines Agency/FDA Application Form for Orphan Medicinal Product Designation
FDA Policy/General
Federal Register notice: FDA has announced the Web site location where it will post two lists of guidance documents that CDRH intends to publish in fiscal year 2018. In addition, the agency has established a docket for accepting comments on priority topics for guidance, proposing draft language for those topics,
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements” that clarifies the requirements for product name placement and prominence in ads. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “FDA Application for Participation in FDA Fellowship Programs” (Formerly Application for Participation in the FDA Commissioner’s Fellowship Program) — OMB Control Number 0910–0780. The information collection involves brief online applications completed by applicants applying to FDA’
Drugs
FDA has posted a final guidance on “Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements.” The document clarifies the agency’s requirements and addresses circumstances under which FDA intends to not take enforcement action in such matters. The guidance recommends that the established name be placed directly
FDA Policy/General
Federal Register notice: FDA has announced a 1/30-31/2018 public workshop entitled “Fostering Digital Health Innovation: Developing the Software Precertification Program.” The workshop is intended to discuss the progress of the agency’s pilot precertification program and to seek input on the program’s ongoing development. The program
FDA Policy/General
Federal Register notice: FDA has announced a 3/15/2018 public meeting entitled “Oncology Center of Excellence (OCE): Listening Session” that is intended for stakeholders to provide input on the Center’s functions. Specifically, the agency seeks comments on OCE’s structure, function, regulatory purview, and activity. To view the
FDA Policy/General
Federal Register notice: FDA is seeking comments on a statement of work to assess current practices when communicating during IND development and identify best practices and areas of improvement. The independent assessment is part of the agency’s user fee performance commitments. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has released its annual report on the status of drug/biologic postmarketing requirements and postmarketing commitments on studies and clinical trials that applicants have agreed to, or are required to, conduct. To view the notice, click here.
FDA Policy/General
FDA commissioner Scott Gottlieb says that across multiple science fields, “we stand at an inflection point in medicine — where new technology is creating foundational opportunities to treat and cure disease in ways that weren’t possible just a short time ago.” He made these remarks during a 12/7 Senate
FDA Policy/General
CNN reports that Otsuka subsidiary Avanir Pharmaceuticals paid a number of doctors who had been disciplined by state medical boards or even had criminal convictions to promote its Nudexta, which is approved by FDA to treat pseudobulbar affect. The network’s investigation found repeated examples of the drug being prescribed
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Pediatric Rare Diseases — A Collaborative Approach for Drug Development Using Gaucher Disease as a Model.” The document proposes for consideration a novel approach to improve drug development efficiency in pediatric rare diseases using Gaucher disease as an example. It
FDA Policy/General
Domestic sales and distribution of antimicrobials approved for use in food-producing animals decreased by 10% from 2015 through 2016, according to a Center for Veterinary Medicine (CVM) summary report. The summary report presents sales and distribution data for the 2016 calendar year for actively marketed antimicrobial drugs approved for
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components.” The document provides recommendations about the use of serological tests to reduce the risk of transmission of such infections in blood
FDA Policy/General
Federal Register notice: FDA has extended the comment period on a 9/8 notice seeking input on existing regulations and related paperwork requirements that could be modified, repealed, or replaced to achieve meaningful burden reduction. Comments now can be submitted until 2/5/2018. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced the names of the members who will serve on its Performance Review Board. The board is directed to provide fair and impartial review of senior executive service (SES), senior professional and Title 42(f) SES Equivalents performance appraisals, bonus recommendations, and pay adjustments. To