News & Insights
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News
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 [...]
Perspective: Update on FDA Review and Enforcement of Non-Tobacco Nicotine Products
Perspective: Update on FDA Review and Enforcement of Non-Tobacco Nicotine Products Source: U.S. FDA Center for Tobacco Products By Brian King, Director of the FDA’s Center [...]
FDA Conducting Evaluation of Key Agency Activities to Strengthen Operations
FDA Conducting Evaluation of Key Agency Activites to Strengthen Operations Source: U.S. FDA July 19, 2022 Dear International Colleague, The following statement is attributed to FDA [...]
Insights
FDA PMTA Denial Orders
FDA PMTA Denial Orders View Warning Letters View Warning Letter Closeouts View Marketing Granted Orders FDA PMTA Denial Orders View Warning Letters View Warning Letter [...]
