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FDA: New Draft Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products

October 31, 2023

FDA’s New Enforcement Policy: A Win for Remote Patient Monitoring and Remote Therapeutic Monitoring Manufacturers

October 30, 2023

FDA Issues New Warning Regarding Compounded Ketamine

October 26, 2023

FDA Laboratory Developed Test Oversight: What Stakeholders Need to Know About Proposed Overhaul

October 10, 2023

DTC Promotional Labeling and Advertisements: Quantitative Efficacy Wins Over FDA in Final Guidance on Presenting Risk Information

September 11, 2023

Clinical Trials: Consent Process Clarified in New FDA Final Guidance

September 8, 2023

Decentralized Clinical Trials: Sponsor Responsibilities

September 6, 2023

Decentralized Clinical Trials: Investigator Responsibilities

July 26, 2023

Key Takeaways from the FDA’s First Draft Guidance on Clinical Trials with Psychedelic Drugs

July 17, 2023

Regulation of Digital Health Products by FDA

July 6, 2023

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Kyle Y. Faget

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