FDA's Compendial—Related Activities

CA Konnor - PDA Journal of Pharmaceutical Science and …, 1986 - journal.pda.org
Compendial Operations Branch is the official liaison between the US Pharmacopeial
Convention. Inc.(USPC) and FDA's Center for Drugs and Biologies. The Branch's …

US pharmacopeia council of experts 2005–2010: Work plans, new revision approaches, and other enhancements

RL Williams - The AAPS journal, 2006 - Springer
Abstract The United States Pharmacopeial Convention (the USP Convention), which meets
at 5-year intervals, last convened in 2005. At that meeting, the convention membership …

[CITATION][C] Communicating with the FDA: the “third rail” of a new model for drug development

DR Stanski, JJ Orloff - The Journal of Clinical Pharmacology, 2008 - Wiley Online Library
In this issue, Wang and colleagues present a new program, the End-of-Phase 2A (EOP2A)
meeting, that has been piloted at the Food and Drug Administration (FDA) during the past …

[PDF][PDF] Reflections on Changes at FDA

EB Sheinin - Pharmaceutical technology, 2001 - alfresco-static-files.s3.amazonaws …
Eric B. Sheinin, PhD, previously served at FDA in various capacities, most recently as
Deputy Director of the Office of Pharmaceutical Sciences at FDA's Center for Drug …

Press Release: American Pharmaceutical Association FDA-CDER Stakeholder Meeting

JA Gans - Journal of Pharmacy Practice, 1998 - journals.sagepub.com
OOD MORNING, AND thank you for this op-G portunity to provide ideas regarding priorities
for the Center for Drug Evaluation and Research. I am John A. Gans, PharmD, Ex-ecutive …

[PDF][PDF] Part D Formularies/Opportunities for Further FDA/CMS Collaboration

J Glaudemans, P Manolakis, PDC Park, B Bruen - 2008 - Citeseer
Summary Under the Medicare Modernization Act (MMA), the Centers for Medicare &
Medicaid Services (CMS) is charged with administering the Medicare Part D outpatient …

Fda's Plan for Action-1985 (Preparing for Drug Review in the 21st Century)

CW Prettyman - Clinical Research Practices and Drug Regulatory …, 1985 - Taylor & Francis
Secretary Margaret M. Heckler has charged the Food and Drug Administration to prepare
itself for the challenges of today's modern technology and science and those of the 21st …

[CITATION][C] FDA Obtains Sought-After PIC/S Membership

J Gouws - Pharmaceutical Technology, 2011

[CITATION][C] Notable Developments in the Pharmacopoeial Revision Program

AP Cotton, B Gauze

[CITATION][C] The United States Pharmacopeia; The National Formulary

United States Pharmacopeial Convention … - 1994 - United States Pharmacopeial …