We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Colleen M. Heisey

Jones Day

Articles

Results 1 to 5 of 152
Most popular |Most recent


The FDA and Cybersecurity: How the Agency is Addressing Cybersecurity Risks to Medical Devices

USA - March 12 2019 As medical devices become more connected to each other and to the internet, an increasing number of patients are exposed to...

J. Todd Kennard, Ian M. Pearson, Samir C. Jain.

FDA Draft Guidance Regarding Inclusion of Pregnant Women in Clinical Trials

USA - June 28 2018 On April 3, 2018, FDA published long awaited draft guidance entitled "Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical...

Maureen Bennett, Ann T. Hollenbeck, Glenn L. Krinsky.

FDA's Evolving Regulation of Artificial Intelligence in Digital Health Products

USA - January 22 2018 FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence. While Congress and FDA have provided...

Maureen Bennett, Ian M. Pearson.

Food, Dietary Supplement & Cosmetics Update Vol. V, Issue 1

USA, European Union - January 12 2018 On January 4, 2018, the U.S. Food and Drug Administration ("FDA") issued a guidance announcing that it does not intend to enforce certain provisions...

Cristiana Spontoni, Marina E. Moreno, Françoise S. Labrousse, Elinor Pecsteen, Ales Bartl Ph.D., Jonathan Berman.

Food, Dietary Supplement & Cosmetics Update Vol. IV, Issue 7

USA, European Union - November 16 2017 The USDA Inspector General ("IG") reviewed the Agricultural Marketing Service's ("AMS") process used in determining whether exporting countries'...

Cristiana Spontoni, Marina E. Moreno, Françoise S. Labrousse, Elinor Pecsteen, Ales Bartl Ph.D., Jonathan Berman.