Showing Publications By: Erika Lietzan
Biosimilar Law and Regulation: An Essential Guide
FDLI MONOGRAPH SERIES vol.2:no.5 (June 2011)
Biosimilar Regulation: Important Considerations and Global Developments
PLC LIFE SCIENCES HANDBOOK (CROSS-BORDER) (2011)
How Should FDA Use Naming and Labeling to Communicate Information about Biosimilars?
FDLI FOOD AND DRUG POLICY FORUM vol.1:no.21 (2011)
Thoughts on Preemption in the Wake of the Levine Decision
13 JOURNAL OF HEALTH CARE LAW AND POLICY 225 (2010)
An Unofficial Legislative History of the Biologics Price Competition and Innovation Act of 2009
65 FOOD AND DRUG LAW JOURNAL 671 (2010)
Biosimilars: What US Regulators Might Learn From Others
SCRIP PHARMA LAW (12/13/2010)
A New History and Discussion of 180-Day Exclusivity
64 FOOD AND DRUG LAW JOURNAL 335 (2009)
FDA in Federal Court: The Agency’s Ten-Year Record
FDLI UPDATE (Feb 2008)
Current Regulatory and Legal Considerations for Follow-On Biologics
85 CLINICAL PHARMACOLOGY AND THERAPEUTICS 633 (2008)
The Food and Drug Administration Amendments Act of 2007
9 BIO-SCIENCE LAW REVIEW 39 (2008)