FDA Summary: July 22, 2022

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For immediate release:

Today, the U.S. Food and Drug Administration provides an at-a-glance summary of news from the agency:

  • Today, the FDA released guidance for industry titled “Failure to Respond to a Complete ANDA Response Letter within Regulatory Timelines”. This guide provides information and recommendations regarding potential courses of action for an Abbreviated New Drug Application (ANDA) applicant after issuance of a Complete Response Letter (CRL) as well as actions the FDA may take. if the requester does not respond to a CRL. This guidance also identifies the information an applicant may submit in their extension request to respond to a CRL as well as a non-exhaustive list of factors that the FDA generally intends to consider in determining whether such a request is reasonable. In this guide, which finalizes the draft published in September 2020, the FDA has added an appendix that provides examples of factors the agency might consider as the basis for concluding that an applicant’s request for a time extension for responding to a CRL is reasonable.
  • Today, the FDA released the guide for industry, “Orange Book Questions and Answers,” which is intended to help potential and current drug applicants and approved application holders use the Orange Book. The guidelines provide answers to questions frequently asked by the FDA from these interested parties regarding the Orange Book and cover topics such as content and format of the Orange Book, requested ANDAs, movement of drug products between sections active and discontinued from the orange book. Lists of books and patents.
  • Today, the FDA announced the availability of a proposed rule “Revised National Drug Code Format and Barcode Requirements on Drug Labels (File No. FDA-2021-N-1351)which aims to minimize the impact of the FDA running out of ten-digit National Drug Codes (NDCs) by adopting a single, uniform 12-digit format for FDA-assigned NDCs. The NDC is the FDA’s standard for the unique identification of drugs marketed in the United States. The FDA is proposing to change the 12-digit NDC with three distinct, consistent segments and a uniform format. Additionally, the FDA is proposing to revise barcode labeling requirements for pharmaceutical products.
  • Today, the FDA released the final guidance, “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Device Identification Database Requirements. device identification for some devices”. These final guidelines include FDA’s compliance policy regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered to be consumer health products. The guidelines also explain that, at this time, the FDA does not intend to enforce GUDID submission requirements for Class I and unclassified devices, other than implantable, life-supporting, or life support, whether or not they are consumer health products, before December 8, 2022. This is a 75-day extension of an existing FDA compliance policy published in the July version 2020 of this guide.
  • On Thursday, the FDA provided another update on Apyx Medical’s Renuvion/J-Plasma device system to inform consumers and healthcare providers of a handpiece that has been cleared by the FDA for use under the skin in certain procedures to improve the appearance of loose skin. . The Renuvion APR Handpiece is cleared for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of loose skin in the neck and submental (under the chin) region. The Renuvion APR Handpiece has not been cleared or approved for use in any other aesthetic skin procedure, or in combination with liposuction.
  • On Wednesday, the FDA announced that its import divisions can detain imports of enoki mushrooms from the Republic of Korea (ROK) without physical examination. This country wide import alert, IA #25-21, “Detention without physical examination of Enoki mushrooms from Korea (Republic of) due to Listeria monocytogenes”, was published to protect public health and help prevent the importation of Enoki mushrooms that may be related to human infections. The FDA issues import alerts to prevent the distribution of potentially infringing products in the United States.
  • On Wednesday, the FDA warned consumers of the potential risk of injury associated with the use of certain brands of ultraviolet (UV) wands because they can expose the user or anyone nearby to dangerous levels of ultraviolet radiation- C (UV-C) and may cause injury to skin, eyes or both after a few seconds of use. The FDA is aware that some manufacturers market unsafe UV wands to consumers for disinfecting surfaces and killing germs in the home or similar spaces outside of most health care settings. The FDA recommends that consumers not use these products and consider using safer alternative methods.
  • On Wednesday, the FDA released draft guidance for industry, Evaluation of Therapeutic Equivalence, which explains FDA’s therapeutic equivalence (TE) evaluations, including the assignment of TE codes. Therapeutic equivalents are approved pharmaceutical products that the FDA has determined to be pharmaceutical equivalents for which bioequivalence has been demonstrated and can be expected to have the same clinical effect and safety profile when are administered to patients under the conditions specified in the labelling. The Agency publishes these draft guidelines as part of its action plan on competition in medicines, which aims to widen access to safe, high-quality and effective generic medicines that can help consumers reduce their costs. health care.
  • On Monday, the FDA issued a supplemental Notice of Proposed Rulemaking to the requirements the FDA proposed in the recent proposed 2021 agricultural water rule. The preharvest agricultural requirements, if finalized, will require covered operations conduct annual systems-based agricultural water assessments to determine and guide appropriate actions to minimize potential risks associated with pre-harvest agricultural water.
  • On June 14, as part of the FDA’s efforts to protect consumers, the agency issued a warning letter to H2 Beverages, Inc. for selling unapproved and mislabeled hydrogen beverage products. as drugs for use in the treatment or prevention of COVID-19 and other diseases. Consumers concerned about COVID-19 should consult their healthcare provider.
  • COVID-19 testing updates:
    • To date, 441 tests and specimen collection devices are authorized by the FDA under Emergency Use Authorizations (EUAs). These include 304 molecular tests and sample collection devices, 85 antibody tests and other immune response tests, 51 antigen tests and 1 diagnostic breath test. There are 80 molecular clearances and 1 antibody clearance that can be used with home samples. There is 1 EUA for molecular prescription home testing, 2 EUA for antigen prescription home testing, 19 EUA for over-the-counter (OTC) antigen home testing and 3 for home testing Molecular OTCs.
    • The FDA has authorized 28 antigen tests and 8 molecular tests for serial screening programs. The FDA also authorized 1035 revisions to EUA clearances.

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The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.


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