Showing Publications By: Erika Lietzan
Federal Regulation of Clinical Research
in MEDICAL BIOTECHNOLOGY: PREMARKET AND POSTMARKET REGULATION, (ABA, 2015)
FDA Regulation of Biosimilars
in FDA IN THE 21ST CENTURY: THE CHALLENGES OF REGULATING DRUGS AND NEW TECHNOLOGIES (eds. Lynch and Cohen, Columbia University Press, 2015).
Biosimilars
in FOOD AND DRUG LAW AND REGULATION, (3rd ed., FDLI, 2015)
The Myths of Data Exclusivity
20 LEWIS AND CLARK REVIEW 91 (2015)
A New Framework for Assessing Clinical Data Transparency Initiatives
18 MARQUETTE INTELLECTUAL PROPERTY LAW REVIEW 33 (2014)
Pharmacy Compounding After the Drug Quality and Security Act
26 HEALTH LAWYER 1 (2013/2014)
The Evolving Regulation of Medical Device Clinical Trials in the USA
JOURNAL OF MEDICAL DEVICE REGULATION (May 2013)
Biosimilar Naming: How Do Adverse Event Reporting Data Support the Need for Distinct Nonproprietary Names for Biosimilars?
FDLI FOOD AND DRUG POLICY FORUM vol.3:no.6 (2013)
The U.S. Biosimilar Pathway Nearly Three Years Later
GxP LIFELINE (Dec 2012)