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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

FDA CARES a Lot About Drug Reporting: Takeaways From Draft Guidance for New Annual 510(j)(3) Reporting Requirement for Released...

Recently, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance titled “Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act” (Draft Guidance)....more

OTC Drug User Facility Fees – Don’t Miss the Changes!

On January 4, 2021, FDA unexpectedly withdrew the notice entitled Fee Rates Under the Over the Counter Monograph User Fee Program for Fiscal Year 2021 stating that it had been ordered to cease further collection efforts...more

Full Speed Ahead – FDA’s Digital Health Center of Excellence to Host Listening Sessions

On September 22, 2020, the U.S. Food and Drug Administration (FDA) announced the establishment of the Digital Health Center of Excellence (DHCE) within FDA’s Center for Devices and Radiological Health (CDRH). Bakul Patel will...more

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