The FDA Law Blog

OCTOBER 16, 2023

Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products.

Documentation 119

Documentation FDA 119

DiversifyRx

NOVEMBER 24, 2023

While DSCSA (the Drug Supply Chain Security Act) enforcement is postponed until November 2024, it is critical to move forward in becoming compliant sooner rather than later. If you think that doesn’t happen nowadays, here’s an article about recent counterfeit HIV medications. To achieve this, the U.S.

Independent Pharmacies 52

Independent Pharmacies Packaging Documentation FDA 52

ISPE

SEPTEMBER 8, 2023

Attendees were invited to submit questions to the FDA representatives. This article offers highlights from the discussion. Please note that views expressed by the panelists are not necessarily representative of the position of the FDA, and that questions and responses are lightly edited for clarity.

FDA 52

FDA Vaccines Documentation 52

ISPE

JULY 6, 2023

This article highlights the overall benefits and scope of Q13, as well as what we see as the next set of opportunities to further expand the adoption of CM across the globe. Since then, agencies have begun officially adopting the guidance, with the FDA doing so in March 2023.

Documentation 52

Documentation Dosage FDA Pharmaceutical Companies 52

ISPE

SEPTEMBER 8, 2023

This article describes the goal of the initiative, characterizes the anticipated challenges to innovation, summarizes the industry’s need to innovate, and discusses regulatory initiatives that are currently in progress, including learnings from the recent pandemic. www.fda.gov/about-fda/oncology-center-excellence/project-orbis.

FDA 52

FDA Dosage Documentation Communication 52