FDA Policy/General
Federal Register notice: FDA has announced a partial withdrawal of a proposed rule published in the 8/21/2003 Federal Register that would have amended the agency’s tentative final monograph (TFM) for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic drug products to include ibuprofen as generally recognized
FDA Policy/General
“The secretary of HHS has a shocking amount of power by the stroke of a pen, and we intend to exercise it,” HHS secretary Alex Azar told PBS News Hour 5/14, addressing the cost of prescription drugs paid by Medicare for senior citizens − an issue FDA commissioner Scott Gottlieb
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval a new proposed information collection entitled “DSCSA Pilot Project Program,” under which the agency would establish the pilot as mandated by the Drug Supply Chain Security Act. It is intended to assist FDA in developing an interoperable, electronic system to identify
FDA Policy/General
FDA Panel To Review Cordis PMA Adverse Events Federal Register notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee reviews a Cordis PMA for the Incraft AAA Stent Graft System. 05/11/2018 Guide on Outsourcing Facility Definition Federal Register notice: FDA makes available a guidance
FDA Policy/General
Federal Register notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee is scheduled to meet 6/12 to review a Cordis PMA for the Incraft AAA Stent Graft System, which is intended for the endovascular treatment of infra-renal abdominal aortic aneurysms in patients with appropriate
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” Section 503B defines an outsourcing facility, in part, as “a facility at one geographic location or address.” FDA has received questions from outsourcing facilities and other stakeholders
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Request for Samples and Protocols” (OMB Control Number 0910–0206). FDA’s regulations give it authority to at any time require manufacturers of licensed biological products to submit samples of any lot along with the protocols showing
FDA Policy/General
Federal Register notice: FDA has determined that GE Healthcare’s sodium iodide I 123 oral solution, 2 millicuries/milliliter was not withdrawn from sale due to safety or effectiveness. The determination will allow FDA to approve ANDAs that cite this reference product. The FDA determination was made in response to
FDA Policy/General
Federal Register notice. FDA has made available a guidance entitled “S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling — Questions and Answers.” The International Council for Harmonization document provides additional information to facilitate interpretation of the guideline for industry “S3A Toxicokinetics:
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment.” The document is intended to assist sponsors in developing new drugs for such conditions. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has established a public docket to assist with its development of a policy/guidance document on assessing drug-drug interactions (DDIs) for therapeutic proteins (TPs). The agency split a 2012 DDI draft guidance into two documents published 10/2017: “In Vitro Metabolism- and Transporter-Mediated Drug-
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act.” The document describes the process that trading partners and stakeholders should use to request such waivers. It also discusses how the
FDA Policy/General
A House Appropriations subcommittee has voted to approve a fiscal year 2019 spending bill that would give FDA a $308 million (10%) boost above the current 2018 spending level. Under the measure, the agency would receive $3.1 billion in discretionary funding, and total funding, which includes user fees, would
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Biotek Inc. Layton, UT (3/13): FDA inspected the firm 8/2017 and cited it over product claims that cause its dietary supplements to be unapproved drugs. For example,
FDA Policy/General
Federal Register notice: FDA is correcting a 4/9 Federal Register notice about OMB approval of several information collection activities. The document was published with an incorrect docket number. The notice now is corrected to read docket number “FDA–2011–N– 0075.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has withdrawn a 1/26/2018 direct final rule to amend its general biologics regulations relating to time of inspection requirements and to also remove duties of inspector requirements. The withdrawal is necessary after FDA received significant adverse comment against the proposal. The agency will now
FDA Policy/General
FDA has qualified the Minnesota Living with Heart Failure Questionnaire from the University of Minnesota as part of its Medical Device Development Tools program. It aims to reduce regulatory burden by qualifying tools that can aid in developing and evaluating devices. Qualified tools can be used by industry to support
FDA Policy/General
FDA Withdraws 3 Sun Pharma ANDAs Federal Register notice: FDA withdraws three Sun Pharmaceutical Industries ANDAs because they are no longer marketed. 05/04/2018 9 No Longer Marketed ANDAs Withdrawn Federal Register notice: FDA withdraws the approval of nine ANDAs from multiple applicants. 05/04/2018 Needle Destruction Device
FDA Policy/General
Federal Register notice: FDA has withdrawn three Sun Pharmaceutical Industries ANDAs because they are no longer marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has withdrawn the approval of nine ANDAs from multiple applicants. The application holders have notified the agency that the drug products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has issued a final order to reclassify the needle destruction device into Class 2 (special controls)and subject to premarket notification. The device has been renamed “sharps needle destruction device.” To view the notice, click here.
FDA Policy/General
FDA commissioner Scott Gottlieb continues to use his bully pulpit to rail against the pharmaceutical industry and its increasing drug costs for American consumers. While the agency has a minimal role in impacting drug costs outside of fostering competition in the generic drug space, Gottlieb nevertheless took the opportunity during