News & Analysis as of

Healthcare › De Novo Standard of Review

Mintz - Health Care Viewpoints

Device Modernization Series: In Vitro Clinical Tests

Mintz - Health Care Viewpoints on

In our first two Device Modernization series posts, we discussed FDA’s 510(k) modernization efforts and the proposed De Novo regulation. FDA has also had a heavy hand in legislative efforts to retool oversight of laboratory...more

Hogan Lovells

FDA proposes new regulations to govern De Novo requests – will the process live up to its promise?

Hogan Lovells on

Last week the Food and Drug Administration (FDA) issued a proposed set of new regulations to further define and update the De Novo review process. Although De Novo review has been available for two decades, for the past 20...more

Robins Kaplan LLP

Shire Development, LLC v. Watson Pharms., Inc.

Robins Kaplan LLP on

Case Name: Shire Development, LLC v. Watson Pharms., Inc., 787 F.3d 1359 (Fed. Cir. June 3, 2015) (Circuit Judges Prost, Chen, and Hughes presiding; Opinion by Hughes, J.) (Appeal from S.D. Fla., Middlebrooks, J.) - Drug...more

3 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:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide