News & Insights

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News

  • Non-Tobacco Nicotine Regulation

FDA Medical Device User Fees FY 2023

FDA Medical Device User Fees FY 2023 The US Food and Drug Administration (FDA) increased their medical device user application fees for the 2023 fiscal year. Federal law authorizes [...]

Insights

FDA PMTA Warning Letter Closeouts

Warning Letter Closeouts View Warning Letters View Denial Orders View Marketing Granted Orders Warning Letter Closeouts View Warning Letters View Denial Orders View Marketing [...]

FDA PMTA Marketing Granted Orders

FDA PMTA Marketing Granted Orders View Warning Letters View Warning Letter Closeouts View Marketing Granted Orders FDA PMTA Marketing Granted Orders View Warning Letters View [...]

FDA PMTA Warning Letters

FDA PMTA Warning Letters View Denial Orders View Warning Letter Closeouts View Marketing Granted Orders FDA PMTA Warning Letters View Denial Orders View Warning Letter [...]