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GW Law China IP Conference 2013

Gilead Citizen Petition

Clinical Data Guidance

Clinical Data Guidance

Acetadote CP denial.pdf

FDLI US-Brazil Program 2012

Jazz's Xyrem Citizen Petition

ACI Clinical Trials 2012

Q1 Productions Regulatory Clearance & Commercialization of Generic Drugs & Biosimilars

ViroPharma Citizen Petition Denial

Team Copaxone

PIV Disputes 2012

Safety Data Collection Guidance

Citizen Petition Regulation Amendments

FY2011

De Novo Guidance

HomeopathicCP

ACI Maximizing Pharmaceutical Patent Life Cycles 2011 NYC

Wasson Associates Corner

Final Rule on Exemption for Substantial Equivalence

FDA Pathway to Global Product Safety and Quality

FLH BIO 2011 Brochure

Alliance Petition Dietary Supplements

Submission of Summary Bio Equivalence Data for ANDAs Guidance

ViroPharma Complaint Dismissed

guidance

Use Code Chart

2011-76-chart

ACIBiosimilars2011

Citizen Petition

Medication Guides--Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)

FDA Response to Generic Boniva Citizen Petition

FDLI Policy Forum Vol 1, Issue 4

PIVDisputes2011

Disentangling Biobetters under the Biologics Price Competition and Innovation Act of 2009

Graphic Health Warnings

Substantial Equivalence Guidance

ACI Patent Term Adjustment and Patent Term Extension Conference 2011

FDA Impact U.S. Medical Technology Innovation

ACI PTA & PTE Conference Program

ANDA Impurity Guidance 2010

ANDA Impurities Guidance

39209531 Viropharma Complaint

CDRH 510(k) FDLI Presentation 3-26-08 -Re Program (00538574) (2)

S. 3677

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