FDA Policy/General
Federal Register notice: FDA is extending the comment period on its draft guidance entitled “Platform Technology Designation Program for Drug Development.” The document provides details about implementing the agency’s Platform Technology Designation Program, which was established by the PREVENT Pandemics Act. It outlines eligibility factors for receiving a platform
FDA Policy/General
The FDA “Annual Report on Inspections of Establishments in FY 2023” says the agency completed 2,953 domestic and foreign drug and medical device establishment inspections. Of that number, the report says, 2,051 inspections were in the U.S., 287 in the European Union, 155 in India, 53 in
FDA Policy/General
Federal Register notice: FDA is announcing that Argenx’s supplemental NDA for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), indicated for treating chronic inflammatory demyelinating polyneuropathy, was approved 6/21 using a priority review voucher. Previously, the drug was approved for treating generalized myasthenia gravis. To view the notice, click
FDA Policy/General
Federal Register notice: FDA is announcing the Cellular and Gene Therapies Interactive Site Tours Program that is intended to give CBER regulatory project managers and reviewers an opportunity to tour biotechnology manufacturing facilities developing cellular and gene therapy products. The program also allows the participants to exchange regulatory experiences with
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of a Takeda NDA for Exkivity (mobocertinib succinate) capsules after the company requested the action in response to a confirmatory study failing to demonstrate the therapy’s clinical benefit. The drug was granted accelerated approval 9/2021 for treating adult patients with locally
FDA Policy/General
Federal Register notice: FDA is making available two draft guidances entitled “Dental Composite Resin Devices — Premarket Notification (510(k)) Submissions” and “Dental Curing Lights — Premarket Notification (510(k)) Submissions.” The documents provide recommendations for device description, performance testing, and labeling to include in 510(k) submissions for dental composite resin
FDA Policy/General
Federal Register notice: FDA is providing notice that a patent infringement lawsuit has been filed against Amgen over its BLA submission for a biosimilar copy of Regeneron’s Eylea (aflibercept), indicated for treating wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. The complaint is titled Regeneron Pharmaceuticals,
FDA Policy/General
Federal Register notice: FDA is making available final guidance entitled “Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder (OUD).” The document provides recommendations on pivotal clinical study designs for such devices. To view the notice, click here.
FDA Policy/General
The Senate Appropriations Committee 7/11 unanimously (27 to 0) marked up and approved FDA’s fiscal year (FY) 2025 budget, which provides $6.87 billion in total funding for the agency, which is about a $170 million (2.5%) boost over the FY 2024 spending measure. It includes $3.
FDA Policy/General
Federal Register notice: FDA is announcing an 8/6 public workshop entitled “Artificial Intelligence (AI) in Drug & Biological Product Development” to bring drug developers and AI experts together to discuss guiding principles for the responsible use of AI in developing drugs and biological products. Topics for discussion include: * Optimizing
FDA Policy/General
Federal Register: FDA is announcing g an 8/2 Genetic Metabolic Diseases Advisory Committee meeting to discuss a Zevra Denmark A/S NDA for arimoclomol, indicated for treating adults and pediatric patients two years of age and older with Niemann-Pick disease Type C. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA makes available a revised draft guidance entitled “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers.” The document describes FDA’s current thinking on common questions firms may have when voluntarily addressing misinformation about their approved/cleared medical products. It revises and replaces a
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products.” The document discusses how a use-related risk analysis, along with other information, can be used to determine human factors data needs during product
FDA Policy/General
Federal Register notice: FDA is announcing an Emergency Use Authorization to the U.S. Centers for Disease Control and Prevention for its in vitro diagnostic device Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set for detecting/diagnosing the monkeypox virus. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has issued Laboratory Corp. of America an Emergency Use Authorization for the Labcorp Monkeypox PCR (Polymerase Chain Reaction) Test Home Collection Kit. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Reclassification Petitions for Medical Devices — 21 CFR Part 860, Subpart C.” The collection supports agency regulations that allow device reclassification petitions to be submitted and require FDA to review these and make a final determination. FDA’s
Biologics
Several law firms have posted analyses of the Supreme Court Loper Bright decision that overturned the 40-year precedent of deference to agency interpretations of ambiguous laws first announced in Chevron. A Sidley Food, Drug, and Medical Device Update says the Supreme Court decision to overturn Chevron deference to agencies
Drugs
FDA says the Web site www.ozempen.com is introducing into interstate commerce misbranded and unapproved new drugs, specifically semaglutide products. A 6/24 Warning Letter says there are “inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances
FDA Policy/General
FDA has published a guidance, Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs, with recommendations for the evaluation of the effectiveness of drugs indicated to prevent heartworm disease caused by Dirofilaria immitis in dogs. The document says the recommendations should be read
FDA Policy/General
FDA is opening an office in the U.S. embassy in Kigali, Rwanda, to provide direct support to the African Medicines Agency (AMA). Announcement of the office was made by FDA associate commissioner for global policy and strategy Mark Abdoo on 6/26 in a presentation at the 2024 Global
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” The document describes the format and content of Diversity Action Plans, including the timing and process for submitting such plans by application or notification type.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Priority Zoonotic Animal Drug Designation and Review Process.” The document is intended to assist sponsors seeking a Priority Zoonotic Animal Drug (PZAD) designation for a new animal drug. It also provides the eligibility criteria for PZAD designation, the process