FDA's New Drug Safety Initiative: One Year Later
by William A. McGrath, Partner in the Food & Drug and Product Safety Practice at Wiley Rein & Fielding LLP, Washington, D.C.

Ethnic/Race Niche Drugs: Navigating Ethnicity and Race in Pharmaceuticals
by William M. Janssen, Litigation Partner and Chair of Life Sciences Practices at the law firm of Saul Ewing LLP , Philadelphia, PA
and
Royce W. Smith, Associate at the law firm of Saul Ewing LLP in Philadelphia, PA
and
Ayanna Maia Lee, Associate at the law firm of Saul Ewing LLP, Philadelphia, PA.

DTC Advertising Hearings: A Decade of Change but Little Agreement
by John F. Kamp, Executive Director of the Coalition for Healthcare Communication and Of Counsel at the law firm of Wiley Rein & Fielding LLP, Washington, D.C.
and
Wayne L. Pines, President of Regulatory Services and Health Care at APCO Worldwide, in Washington, D.C.

Increased Scrutiny of Investor Communications by Federal Regulators
by Carolyne R. Hathaway, Partner in the Washington D.C. office of Latham & Watkins LLP
and
John R. Manthei, Partner in the Washington D.C. office of Latham & Watkins LLP
and
J. Ben Haas, Associate in the Washington D.C. office of Latham & Watkins LLP.

The Complex Web of Pharmaceutical Promotion Regulation
by Frederick Robinson, Partner in the law firm of Fulbright & Jaworski, LLP, Washington, D.C.
and
Lara Parkin, Associate in the law firm of Fulbright & Jaworski LLP, Washington, D.C.

Medical Device Recalls—Current Controversy and Proposed Changes
by Ralph F. Hall, Visiting Associate Professor of Law, University of Minnesota Law School and Counsel to the law firm of Baker & Daniels in Indianapolis, Indiana and Washington, D.C.

UCC Does Not Apply to Structured Settlement of Tort Claim
by Mike C. Buckley, Member of Reed Smith LLP's Commercial Restructuring & Bankruptcy Group, Oakland, CA
and
James M. Wood, Member of Reed Smith LLP's Product Liability Group, Oakland, CA.

History Corner
Drugs and Biologics: Safety and Availability
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration, Rockville, MD.

Enforcement Corner
Disclosures to Auditors and Privilege Waivers—Another Headache
by Steven M. Kowal, Chair of the White Collar Criminal Defense Group at the law firm of Bell, Boyd & Lloyd LLC , Chicago, IL.

Global Corner
Current Challenges Facing Industry in Ensuring Vaccine Availability
by Matthew R. Weinberg, Chief Executive Officer, THE WEINBERG GROUP, Washington, D.C.

Canadian Corner
Listing Patents Under Canada's PMNOC Regulations
by Brian Daley, Partner in the law firm of Ogilvy Renault in Montreal, Quebec, Canada.

Associates' Corner
Presenting the Major Statement in DTC Prescription Drug Broadcast Advertisements by Tiffany A. Towers, Associate with Davis & Gilbert LLP, New York, NY