FDA Policy/General
FDA has published a guidance, Priority Zoonotic Animal Drug Designation and Review Process, to assist sponsors pursuing Priority Zoonotic Animal Drug (PZAD) designation of a new animal drug. The document is intended to provide: * the definition of a PZAD; * eligibility criteria for PZAD designation; * the process for PZAD designation requests;
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a proposed information collection entitled “Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot.” The pilot was agreed upon as part of the medical device user fee commitments for fiscal year (FY) 2023 through FY 2027. The agency says the program
FDA Policy/General
Federal Register notice: FDA is requesting comments on its “Information Technology (IT) Strategy” and ‘”Customer Experience (CX) Strategy.” Under the agency’s user fee program commitments, it must annually update and publish its IT Strategy by 9/30. The initial strategy was published 9/2023 and it outlined the future
FDA Policy/General
The Public Citizen Health Research Group says there are three things FDA can do to optimize its use of and processes for advisory committees. In a comment letter, Public Citizen recommends that the agency: * maintain or perhaps expand voting questions as a central feature of advisory committee meetings; * release sponsor
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Laboratory Developed Tests (LDTs): Small Entity Compliance Guide.” The document is intended to help small entities comply with applicable medical device regulations, consistent with the LDT final rule, including a phase-out of FDA’s general enforcement discretion approach
FDA Policy/General
Federal Register notice: FDA is announcing a 7/22 public workshop entitled “Best Practices for Meeting Management” to discuss issues related to submission of meeting requests, efficient time management, finalizing meeting agendas, development and submission of meeting background packages, and lessons learned from the Covid-19 pandemic including the use
FDA Policy/General
Federal Register notice: FDA is announcing a publication containing modifications it is making to the list of standards FDA recognizes for use in premarket reviews. This publication, “Modifications to the List of Recognized Standards, Recognition List Number: 062,” is intended to assist manufacturers who elect to declare conformity with consensus
FDA Policy/General
Federal Register notice: FDA has determined that Janssen Pharmaceuticals’ Invega (paliperidone) extended-release tablet, 1.5 mg, was not withdrawn from sale due to safety or effectiveness reasons. The determination will allow FDA to continue to approve ANDAs that referenced the product as long as they meet relevant legal and
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “‘Considerations in Demonstrating Interchangeability With a Reference Product: Update.” The document describes considerations about a switching study or studies intended to support a demonstration that a proposed therapeutic protein product is interchangeable with a reference product. FDA says regulatory
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection.” The document reflects changes in the FDA Reauthorization Act of 2017 so that, as is the case with a drug, a device is deemed to be
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Human User Safety in New and Abbreviated New Animal Drug Applications.” The document addresses general principles of human user safety (HUS) assessment for new animal drugs, sources of data, mitigation strategies for proposed new animal drugs, potential recommendations to
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 20 ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested they be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is correcting a 3/29 notice on the approval withdrawals of 30 ANDAs from multiple applicants, effective 4/29. The document in error indicated that five ANDAs held by Target Health were being withdrawn. However, Target had timely requested that the approvals not be withdrawn, and
FDA Policy/General
FDA has published a guidance, Human User Safety in New and Abbreviated Animal Drug Applications, clarifying the current approaches and recommendations the Center for Veterinary Medicine (CVM) uses for human user safety (HUS) assessment and submission of HUS information to support the overall safety of proposed new animal drugs before
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Facility Readiness: Goal Date Decisions Under GDUFA.” The document provides information to applicants on how FDA will use information related to a facility’s readiness for inspection to set a goal date for an original ANDA. It incorporates a
FDA Policy/General
Federal Register notice: FDA is announcing a 7/17 educational conference (public meeting) entitled “First Annual Animal Drug User Fee Educational Conference.” This is the first of five annual educational conferences FDA will host as described in the ‘‘Animal Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years
FDA Policy/General
FDA Webview’s newsroom will be closed Wednesday 6/19 in recognition of the federal holiday Juneteenth. We resume our normal news operations on 6/20.
FDA Policy/General
Federal Register notice: FDA is issuing a final rule revising its requirements for current good manufacturing practice, postmarketing safety reporting, and labeling that apply to certain medical gases. The final rule also establishes regulations on certification of designated medical gases. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is correcting a 5/23 notice announcing the availability of a draft revised guidance #115 (VICH GL22) entitled “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1).” The document erroneously included incorrect contact information and this notice corrects
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics,” which provides recommendations for developing oligonucleotide therapeutics. It addresses FDA’s current thinking about clinical pharmacology considerations and recommendations for oligonucleotide therapeutic development programs, including characterizing the potential for QT
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Diabetic Foot Infections: Developing Drugs for Treatment.” The document addresses FDA’s current thinking about the overall development program and clinical trial designs for developing drugs to support an indication for treating diabetic foot infections. To view the notice,
FDA Policy/General
Federal Register notice: FDA is announcing a proposed administrative order entitled “Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use.’’ The proposed order, if finalized, will require a warning on the labeling of such OTC drug products containing acetaminophen to