fda-lawyers-blog documents

Q1 Productions Regulatory Clearance & Commercialization of Generic Drugs & Biosimilars
Documents Q1 Productions Regulatory Clearance & Commercialization of Generic Drugs & Biosimilars
PIV Disputes 2012
Documents PIV Disputes 2012
ViroPharma Citizen Petition Denial
Documents ViroPharma Citizen Petition Denial
Jazz's Xyrem Citizen Petition
Documents Jazz's Xyrem Citizen Petition
FLH BIO 2011 Brochure
Documents FLH BIO 2011 Brochure
ACIBiosimilars2011
Documents ACIBiosimilars2011
ACI Patent Term Adjustment and Patent Term Extension Conference 2011
Documents ACI Patent Term Adjustment and Patent Term Extension Conference 2011
Gilead Citizen Petition
Documents Gilead Citizen Petition
ACI Clinical Trials 2012
Documents ACI Clinical Trials 2012
FDA Response to Generic Boniva Citizen Petition
Documents FDA Response to Generic Boniva Citizen Petition
Disentangling Biobetters under the Biologics Price Competition and Innovation Act of 2009
Documents Disentangling Biobetters under the Biologics Price Competition and Innovation Act of 2009
GW Law China IP Conference 2013
Documents GW Law China IP Conference 2013
FDLI US-Brazil Program 2012
Documents FDLI US-Brazil Program 2012
Safety Data Collection Guidance
Documents Safety Data Collection Guidance
Citizen Petition Regulation Amendments
Documents Citizen Petition Regulation Amendments
De Novo Guidance
Documents De Novo Guidance
HomeopathicCP
Documents HomeopathicCP
ACI Maximizing Pharmaceutical Patent Life Cycles 2011 NYC
Documents ACI Maximizing Pharmaceutical Patent Life Cycles 2011 NYC
Wasson Associates Corner
Documents Wasson Associates Corner
Final Rule on Exemption for Substantial Equivalence
Documents Final Rule on Exemption for Substantial Equivalence
FDA Pathway to Global Product Safety and Quality
Documents FDA Pathway to Global Product Safety and Quality