On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more
Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more
1/28/2025
/ Artificial Intelligence ,
Bias ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Public Health ,
Regulatory Agenda ,
Transparency
On January 6, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway” (the “Draft...more
On December 5, 2024, just in time for the holidays, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Expedited Program for Serious Conditions: Accelerated Approval of Drugs and...more
Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance, “Key Information and Facilitating Understanding in Informed Consent”, with notable implications for clinical trial sponsors,...more
On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more
9/27/2023
/ Digital Health ,
Draft Guidance ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Reform ,
Labeling ,
Life Sciences ,
Marketing ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Requirements
Providing further clarification to drug manufacturers about specific costs that can be charged for investigational drugs used in clinical and expanded access trials...more