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The End of an Era: FDA Announces Disposition Plans for COVID-19 Related Guidance Documents

The COVID-19 pandemic presented the U.S. Food and Drug Administration (FDA or Agency) with a monumental task of shifting its operations and the way it approached the regulation of critical drugs, medical devices, and biologic...more

FDA Proposes New Exemptions From IND Regulations for Certain Drug Use Clinical Studies of Food, Dietary Supplements, and Cosmetic...

In what could be a game-changer to the dietary supplement and food industry, the U.S. Food and Drug Administration (FDA or Agency) is proposing to amend the investigational new drug (IND) regulations to exempt clinical...more

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