 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: - Today, the FDA published the guidance for industry entitled "Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe." This guidance provides information and recommendations regarding potential courses of action for an abbreviated new drug application (ANDA) applicant after the issuance of a complete response letter (CRL) as well as the actions that the FDA may take if the applicant fails to respond to a CRL. This guidance also identifies information that an applicant may submit in its request for an extension 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 guidance, which finalizes the draft published in September 2020, the FDA added an appendix that provides examples of factors that the agency could consider as the basis for concluding that an applicant's request for an extension of time to respond to a CRL is reasonable.
- Today, the FDA published the guidance for industry, "Orange Book Questions and Answers," which is intended to assist prospective and current drug product applicants and approved application holders in using the Orange Book. The guidance provides answers to commonly asked questions FDA has received from these interested parties regarding the Orange Book and covers topics such as the content and format of the Orange Book, petitioned ANDAs, the movement of drug products between the Active and Discontinued sections in the Orange Book, and patent listings.
- Today, FDA announced the availability of a proposed rule "Revising the National Drug Code Format and Drug Label Barcode Requirements (Docket No. FDA-2021-N-1351)," that is intended to minimize the impact of 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 standard for uniquely identifying drugs marketed in the United States. The FDA is proposing to change the NDC to 12 digits in length with three distinct and consistent segments and one uniform format. Additionally, the FDA is proposing to revise the drug product barcode label requirements.
- Today, the FDA posted the final guidance, "Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices." This final guidance includes the FDA's compliance policy regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products. The guidance also explains 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-sustaining devices, regardless of whether they are consumer health products, before Dec. 8, 2022. This is a 75-day extension of an existing FDA compliance policy published in the July 2020 version of this guidance.
- On Thursday, the FDA provided another update on the Renuvion/J-Plasma device system by Apyx Medical to inform consumers and health care providers about a handpiece that has been FDA cleared for use under the skin in certain procedures to improve the appearance of loose skin. The Renuvion APR Handpiece is cleared to be used 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 may detain without physical examination, importations of enoki mushrooms from the Republic of Korea (ROK). This country-wide import alert, IA #25-21, "Detention Without Physical Examination of Enoki Mushrooms from Korea (the Republic of) due to Listeria monocytogenes," was issued to protect public health and help prevent the importation of enoki mushrooms that could be linked to human infections. The FDA issues import alerts to help prevent potentially violative products from being distributed in the United States.
- On Wednesday, the FDA warned consumers about the potential risk of injury associated with the use of certain brands of ultraviolet (UV) wands because they may expose the user or any nearby person to unsafe levels of ultraviolet-C (UV-C) radiation and may cause injury to the skin, eyes, or both after a few seconds of use. The FDA is aware that some manufacturers are marketing unsafe UV wands to consumers to disinfect surfaces and kill germs in the home or similar spaces outside most health care settings. The FDA recommends that consumers do not use these products and consider using safer alternative methods.
- On Wednesday, the FDA published the draft guidance for industry, Evaluation of Therapeutic Equivalence, which explains the FDA's therapeutic equivalence (TE) evaluations, including the assignment of TE codes. Therapeutic equivalents are approved drug products that the FDA has determined are pharmaceutical equivalents for which bioequivalence has been demonstrated and that can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling. The Agency is issuing this draft guidance as part of our Drug Competition Action Plan, which seeks to expand access to safe, high-quality, effective generic medicines that can help consumers lower their health care costs.
- On Monday, the FDA issued a supplemental notice of proposed rulemaking to requirements that FDA proposed in the recent 2021 agricultural water proposed rule. The pre-harvest agricultural requirements, if finalized, will require covered farms to conduct annual systems-based agricultural water assessments to determine and guide appropriate measures to minimize potential risks associated with pre-harvest agricultural water.
- On June 14, as part of the FDA's effort to protect consumers, the agency issued a warning letter to H2 Beverages, Inc. for selling unapproved and misbranded hydrogen-infused water beverage products as drugs for use in treating or preventing COVID-19 and other diseases. Consumers concerned about COVID-19 should consult with their health care provider.
- COVID-19 testing updates:
- As of today, 441 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 304 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 80 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
- The FDA has authorized 28 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1035 revisions to EUA authorizations.
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