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  1. 2022年5月2日 · 标题:FDA 致力保护消费者免受潜在有害的非处方美白产品的危害. Linkedin. [2022 年 4 19 ] FDA 向 12 家公司发出 警告信 ,因为它们销售的含有氢醌 ...

  2. This rule, which became final in September 2015, requires food facilities to have a food safety plan in place that includes an analysis of hazards and risk-based preventive controls to minimize or ...

  3. www.fda.gov › drugs › drug-safety-and-availabilityDrug Shortages | FDA

    • Overview
    • COVID-19, Shortages
    • Ibuprofen Supply
    • Ninth Annual Report
    • CDER's Efforts

    This article is about the efforts of the FDA's Center for Drug Evaluation and Research (CDER) in monitoring and mitigating drug shortages due to COVID-19, including asking manufacturers to evaluate their entire supply chain, working closely with them on preventing or reducing impact of shortages, issuing guidance to increase supply of ibuprofen ora...

    The FDA continues to monitor the supply chain and has asked manufacturers to evaluate their entire supply chain due to the COVID-19 outbreak. Manufacturers provide most drug shortage information, and the agency works closely with them to prevent or reduce shortages. Report a shortage at DRUGSHORTAGES@fda.hhs.gov.

    The FDA issued guidance in January 2023 to help increase ibuprofen oral suspension products in hospitals and health systems, while continuing close monitoring of pediatric ibuprofen and acetaminophen supplies which have experienced increased demand since fall 2022 due to respiratory illnesses increases.

    A report is available on drug shortages for calendar year 2021 as PDF file with 462KB size.

    CDER's Coronavirus Aid, Relief, and Economic Security Act (CARES Act) efforts are related to drug shortage mitigation efforts by the agency .

  4. 2024年3月29日 · 510(k), De Novo, and PMA 4: medical device submissions for Non-In Vitro Diagnostic devices 0910-0120, 0910-0844, 0910-0231 In Vitro Diagnostic (IVD) eSTAR Version 5

  5. www.fda.gov › drugs › drug-safety-and-availabilityDrug Recalls | FDA

    A recall is a voluntary action taken by a company to remove a defective drug product from the market or warn patients and consumers about a potential risk. The list below includes voluntary drug ...

  6. 2022年11月29日 · November 29, 2022. The FDA is issuing Edition 5 (Final Guidance) to replace Edition 4 (Final Guidance), released in 2006. Edition 5 (Final Guidance) contains the questions and answers from Edition ...

  7. Find an authorized drug collection site near you or call the DEA Diversion Control Division Registration Call Center at 1-800-882-9539 for more information about these collection sites. These ...