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FDA 2019 Year in Review

USA - January 13 2020 2019 was a robust year for the US Food and Drug Administration’s (FDA’s) regulatory agenda. The agency continued to implement initiatives and...

Vernessa T. Pollard, Gugan Kaur, Alva C. Mather, Michael W. Ryan.

Is Your Software a Medical Device? FDA Issues Six Digital Health Guidance Documents

USA - October 3 2019 The 21st Century Cures Act, enacted in December 2016, amended the definition of “medical device” in section 201(h) of the Federal Food, Drug, and...

Vernessa T. Pollard, Gugan Kaur, Michael W. Ryan.

Reviewing Key Principles from FDA’s Artificial Intelligence White Paper

USA - August 28 2019 In April 2019, the US Food and Drug Administration (FDA) issued a White Paper, “Proposed Regulatory Framework for Modifications to Artificial...

Vernessa T. Pollard.

Modernizing FDA’s New Drugs Regulatory Program - Reviewing the Guidance Ecosystem and Implications for Life Sciences Companies

USA - August 22 2019 In 2016, Congress passed the 21st Century Cures Act (Cures Act), which contained provisions to help accelerate medical product innovation while...

FDA’s Breakthrough Device Program: Opportunities and Challenges for Device Developers

USA - July 24 2019 As part of the 21st Century Cures Act, Congress gave the US Food and Drug Administration (FDA) the authority to establish a Breakthrough Devices...

Vernessa T. Pollard.