Food and Drug Administration

Advisory Committee for Pharmaceutical Science

May 7-8, 2002

Briefing Information

Table of Contents htm   doc  pdf

May 8, 2002

Analytical Technologies (PAT): Closing Remarks, Ajaz Hussain, PhD Deputy Director, OPS   pdf   ppt   

Chemometric Working Group  ppt  htm

Product & Process Working Group  ppt  htm

Process Analytical Technologies (PATs), Applications & Benefits Working Group  ppt  htm

Process & Analytical Validation Working Group  ppt  htm

Guidance for Industry: ANDAs: Blend Uniformity Analysis, Draft Guidance, August 3, 1999  pdf

Letter dated March 28, 2002 from PQRI to Janet Woodcock, MD, Dir, CDER, FDA  pdf

Decision Tree #4 Investigating the Need to Set Acceptance Criteria for Polymorphism in Drug Substances and Drug Products  pdf

International Conference on Harmonization Guidance on Q6A Specifications (December 29, 2000, 65FR83041) pdf

Particle Size and Polymorph of Drug Substance Summary Slides ppt  htm

Issues of Polymorphism and Abbreviated New Drug Applications  htm  doc  pdf

April 15, 2002 Response to Arnold & Porter on Citizen Petitions (Docket No. 00P-1550/CP1 & PSA1; Dockets No. 01P-0428/CP1 & PSA1)  pdf

Agency Position on Polymorphism and Abbreviated new Drug Applications  pdf

Approved Drug Products  pdf

USPC, Inc. Chloramphenicol Palmitate Oral Suspension  pdf

USPC, Inc. Idarubicin Hydrochloride  pdf

Guidance For Industry: Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances  pdf

Bibliography htm  doc pdf