FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension on “Focus Groups as Used by the Food and Drug Administration (All FDA-Regulated Products).” FDA conducts focus group interviews on many topics involving FDA-regulated products, including drugs, biologics, devices, food, tobacco, and veterinary medicine. It uses
FDA Policy/General
Federal Register notice: FDA is seeking comments on a revised information collection on “Registration of Human Drug Compounding Outsourcing Facilities and Associated Fees Under Section 503B of the FD&C Act” (OMB Control Number 0910-0776). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection entitled “Medical Devices; Reports of Corrections and Removals — 21 CFR part 806” (OMB Control Number 0910–0359). The collection supports FDA regulations that require, within 10 working days of initiating any action to correct or remove a device to
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a TV ad for Xeris Pharmaceuticals’ Gvoke (glucagon) injection for subcutaneous use makes false or misleading claims and representations about the risks associated with and efficacy of Gvoke. An 8/14 Notice of Violation says the violations are concerning from a
FDA Policy/General
Federal Register notice: FDA has submitted to OMB and information collection extension for “Customer/Partner Service Surveys” (OMB Control Number 0910–0360). FDA intends to use the information from the surveys to identify strengths and weaknesses in service to customers/partners and to make improvements. They will measure timeliness, appropriateness
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c). The document describes FDA’s policy concerning the conditions under which it generally does not intend to take regulatory action against an
FDA Policy/General
Federal Register notice: FDA has issued a stay of regulatory effectiveness provisions banning electrical stimulation device use on certain self-injurious or aggressive behavior individuals. FDA is publishing the notice in response to petitions for an administrative stay of action in accordance with regulatory requirements. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has added a statement to the docket of a 2/4 public meeting on “Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc” to clarify that a subsequent posted executive summary is not agency recommendations. The agency says the executive summary and related presentations
FDA Policy/General
Federal Register notice: FDA is revising its regulations to reflect changes to the agency’s organizational structure, including the reorganization of the Office of Regulatory Affairs. The revisions update addresses and replace references to the district officials with references to division officials. It does not impose any new regulatory requirements
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Dispute Resolution Procedures for Science-Based Decisions on Products by the Center for Veterinary Medicine — 21 CFR 10.75” (OMB Control Number 0910-0566). The collection supports an agency guidance that describes the process by which CVM
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Food and Drug Administration Rapid Response Surveys” (OMB Control Number 0910-0500). The collection covers surveys for community-based healthcare professionals, general type medical facilities, specialized medical facilities, patients, consumers, and risk managers working in facilities containing
FDA Policy/General
Federal Register notice: FDA has issued a final guidance entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.” The document outlines how the agency plans to identify whether responsible parties have failed to submit required clinical trial registration or results information to ClinicalTrials.gov. It also discusses how
FDA Policy/General
Federal Register notice: FDA is proposing to reclassify non-invasive bone growth stimulators from postamendments Class 3 devices into Class 2 (premarket notification). Non-invasive bone growth stimulator devices provide stimulation through electrical and magnetic fields to facilitate the healing of nonunion fractures and lumbar spinal fusions. To view the
FDA Policy/General
Federal Register notice: FDA has amended a 7/23 notice about a 9/15 Pediatric Advisory Committee meeting. The amendment reflects a change in the procedure portion of the notice — oral presentations from the public will be scheduled between 11:30 am to 12:30 pm eastern time. To view
FDA Policy/General
Federal Register notice: FDA has made available two final device-specific guidance documents for its Safety and Performance Based Pathway: “Cutaneous Electrode for Recording Purposes — Performance Criteria for Safety and Performance Based Pathway” and “Conventional Foley Catheters — Performance Criteria for Safety and Performance Based Pathway.” To view the notice, click
FDA Policy/General
Federal Register notice: FDA has announced a 10/30 public workshop entitled “New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation.” The workshop provides an opportunity for public comments/feedback on the “integrated review” documentation generated by the new assessment of marketing
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment.” The document addresses FDA’s current thinking on the overall development program and clinical trial designs for developing drugs and biological products to support an indication for treating AML,
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection entitled “Medical Devices; Humanitarian Use Devices (HUD) — 21 CFR Part 814” (OMB Control Number 0910-0332). The collection supports the agency’s authorization to exempt an HUD from effectiveness requirements. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Electronic Records; Electronic Signatures — 21 CFR Part 11” (OMB Control Number 0910-0303). The collection pertains to FDA criteria for accepting electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records.
FDA Policy/General
FDA commissioner Stephen Hahn told an 8/10 teleconference of doctors and other healthcare professionals that the agency needs their help in communicating to patients that all FDA Covid-19 decisions are based on science. “I want to reassure you that the decisions that FDA will have to make in
FDA Policy/General
Federal Register notice: FDA has announced a 10/2 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2021 southern hemisphere influenza season. To view the notice,
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format.” The document recommends content for the marketing status notifications, the format for submitting them, and the timelines for submission. To view the