Issue 2 : March/April 2001
Biologics & Biotechnology
March/April 2001
Subscription Information
FDLI members receive Update as part of membership.
Additional
copies or back issues are available at $15 each.
Biologics Update
by Edward L. Korwek and Mark D. Learn
Biologics, Biotechnology, Comparability, and Generics—Back
to the Past
by Curtis Scribner
Biologic Approvals for Small Businesses
by Kurt R. Karst and Frank J. Sasinowski
The Medicine Equity and Drug Safety Act of 2000
by Erika King
Attention Device Manufacturers: Beware of the False Claims Act
by Robert L. Vogel
PPA: What's on the Horizon?
by Joseph McMenamin and Brickford Y. Brown
Failure Investigations and Why They Frequently Fail
by Gerald E. Vince
EduNeering Partners With FDA to Create an Online University
by Janice McFarland
FDLI Forms New Oversight Committees
by Michael Peskoe, Kristine Rapp, and Christopher Hagenbush
Enforcement Corner
Enforcement Focus on Clinical Research
by Steven M. Kowal
Making History
A Revolution in Vaccine Research and Development
by Suzanne White Junod, Ph.D.
Global Corner
The European Union's Legal System—Opening Into a New World
by Myron S. Weinberg
Associates' Corner
Reassessing Hatch-Waxman Incentives
by William E. Holtz
(Note: All author affiliations are current as of the date of publication of the issue.)