Intellectual Property Law
New Matter SUMMER 2017 Volume 42, Number 2
Content
- 2017 New Matter Author Submission Guidelines
- Case Comments
- Contents
- Copyright Commentary
- Federal Circuit Report
- Intellectual Property Section Executive Committee 2016-2017
- Intellectual Property Section Interest Group Representatives 2016-2017
- Ip and Art: An International Perspective
- Letter from the Chair
- Letter from the Editor-in-Chief
- Ninth Circuit Report
- Online Cle For Participatory Credit
- Standing Still: Denial of Certiorari in Belmora Llc v. Bayer Consumer Care Ag Leaves Question on Standing for Foreign Plaintiff's Unfair Competition Claims
- The Band Who Must Not Be Named: Summary of Briefs and Oral Hearing in Lee v. Tam
- The Licensing Corner
- The State Bar of California Intellectual Property Alumni
- Ttab Decisions and Developments
- Federal Government Expands Public Disclosure Requirements For Clinical Trials: Product Developers Must Publish More Detailed Information, Study Protocols, and the Results of Studies of Unapproved/Unmarketed Products
Federal Government Expands Public Disclosure Requirements For Clinical Trials: Product Developers Must Publish More Detailed Information, Study Protocols, and the Results of Studies of Unapproved/Unmarketed Products
CHRISTINA M. MARKUS
King & Spalding
BEVERLY H. LORELL, M.D.
King & Spalding
ELAINE H. TSENG
King & Spalding
Pharmaceutical, biological product, and medical device developers must confirm their readiness for the newest stage of clinical trial information disclosure. In response to historical concerns that primarily leading-edge and positive data were being published (while less novel or unfavorable data were sometimes unpublished), federal law since late 2007 has required public registration (i.e., disclosure of the existence, general design, and status of specified clinical trials), and the posting of basic results summaries, in the publicly accessible data bank ClinicalTrials.gov.