FDA’s Implementation of FDAAA’s Food-Related Provisions: A Work in Progress

by Ricardo Carvajal, Of Counsel with the law firm of Hyman, Phelps & McNamara PC, Washington, DC

and

Diane McColl, Director with the law firm of Hyman, Phelps & McNamara PC, Washington, DC

FDAAA’s Safety Labeling Provisions

by Scott D. Danzis, Partner with the law firm of Covington & Burling LLP, Washington, DC

and

Sarah E. Pitlyk, Associate with the law firm of Covington & Burling LLP, Washington, DC

REMS: Experience and Future Directions

by Edgar H. Adams, Executive Director, Epidemiology at Covance Inc., Princeton, NJ

Clinical Trial Registration and Results Reporting: ClinicalTrials.gov and FDAAA
by Tony Tse, Program Analyst of ClinicalTrials.gov, Rockville, MD

and

Deborah A. Zarin, Director of ClinicalTrials.gov, Rockville, MD

Postmarket Surveillance: Progress and Prospects One Year After FDAAA
by Elaine H. Tseng, Partner in the law firm of King & Spalding LLP, San Francisco, CA

Caution – The FDA Could Be Hazardous to Your Health
by Steve Brozak, President, WBB Securities, an independent broker-dealer and investment bank, Westfield, NJ

Warning to Investors in Small Pharmaceutical and Biotech Companies: SBA May Be Hazardous to Your Health
by Paul D. Rubin, Partner in the law firm of Patton Boggs LLP, Washington, DC

and

Smitha G. Stansbury, Senior Associate in the law firm of Patton Boggs LLP, Washington, DC

What Does “Used For Regulatory Purposes” Really Mean?
by Michael J. Gregor, President and Chief Executive Officer of Compliance Gurus Inc., Boston, MA

Promotion of Drugs and Devices At International Conferences Held in Canada

by Eileen McMahon, Co-chair of the Food and Drug Regulation/Intellectual Property Practice, Torys LLP, Toronto, Canada

and

Laila Paszti, Student-at-law, Torys LLP, Toronto, Canada