News & Analysis as of

Risk Management Draft Guidance Public Comment

Sterne, Kessler, Goldstein & Fox P.L.L.C.

FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues New Draft Cybersecurity Guidance for Medical Devices

The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more

Holland & Hart LLP

Corps of Engineers to Streamline Section 408 Permitting Process

Holland & Hart LLP on

In February 2018, the U.S. Army Corps of Engineers (“Corps”) issued a draft Engineering Circular (“EC”) outlining proposed policies and procedures regarding how it will address third-party requests to alter civil works...more

Downey Brand LLP

Draft 408 Guidance imminent; USACE Webinars Scheduled

Downey Brand LLP on

Happy New Year!!!!!! Yes, it is actually February, but it is a new year for this blog as we turn our attention to a world full of flood risk reduction actions in the second year of the Trump Administration. We are hearing...more

4 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide