Performance Improvement 1999. Drug Application Review

02/01/1999

TITLE: Develop and Validate Toxicology Predictive Modeling Systems

ABSTRACT: The reproductive toxicity predictive module is expected to assist review divisions in evaluating the potential reproductive risks to female subjects in association with early clinical trials of drugs that have not yet been tested for reproductive toxicity. Commercial distribution of the modules is expected to generate resources that can be used to support the maintenance, improvement and development of toxicology prediction software.

AGENCY SPONSOR: Center for Drug Evaluation and Research

FEDERAL CONTACT: Ed Matthews

PHONE NUMBER: 301-827-5188

PIC ID: 7105

PERFORMER ORGANIZATION: Center for Drug Evaluation and Research, FDA, Rockville MD

PROJECTED DATE OF COMPLETION: 6/20/99
 

TITLE: Methods Validation

ABSTRACT: This project seeks to verify the suitability of NDA and ANDA analytical methods for drugs, antibiotics and hormones for quality control and regulatory purposes.

AGENCY SPONSOR: Center for Drug Evaluation and Research

FEDERAL CONTACT: Joe Hanig

PHONE NUMBER: 301-594-5026

PIC ID: 7106

PERFORMER ORGANIZATION: Center for Drug Evaluation and Research, FDA, Rockville MD

PROJECTED DATE OF COMPLETION: 9/30/00
 

TITLE: Review of Therapeutic Agents as an Antimicrobial Adjunct in Treatment of Sepsis

ABSTRACT: Sepsis affects half a million people annually. Even though a large number of trials have been conducted, no therapeutic agent demonstrating clinical benefit or superiority to standard care has been identified. Designing clinical trials that have any probability of demonstrating efficacy is challenging, due to the heterogeneity of patient populations, poor understanding of the pathophysiology of acute sepsis, and lack of uniformly accepted standards of care in international trials. Intensive efforts have been undertaken by the Food and Drug Administration (FDA) to propose the optimal trial design and prospective analysis plans. Currently, an analysis of the failed sepsis trials is being initiated by the FDA in the hopes of better clinical trials for the evaluation of the adjunctive therapy of sepsis in the future.

AGENCY SPONSOR: Center for Drug Evaluation and Research

FEDERAL CONTACT: Rosemary Roberts, Ph.D.

PHONE NUMBER: 301-827-2183

PIC ID: 6736

PERFORMER ORGANIZATION: Center for Drug Evaluation and Research, FDA, Rockville MD

PROJECTED DATE OF COMPLETION: 10/1/00
 

TITLE: Drug Metabolism: Drug-Drug Interactions

ABSTRACT: Recent examples of studies that have provided information to specific review decisions include: (1) interactions and metabolism studies of anti-cancer drugs such as paclitaxel, (2) anti-abuse drugs such as LAAM, (3) anti-HIV drugs such as the protease inhibitors, (4) anti-epileptic drugs, (5) cardiovascular drugs, and (6) anti-malarial drugs. In addition to the general technical expertise brought to bear on these problems, results from the program have been incorporated into final product labeling for some drugs, including paclitaxel and saquinavir. Labeling changes for other drugs are under discussion. Also, cutting-edge issues regarding cases of intermediate potency for cytochrome P450 pathways are under investigation.

AGENCY SPONSOR: Center for Drug Evaluation and Research

FEDERAL CONTACT: Jerry Collins

PHONE NUMBER: 301-427-1065

PIC ID: 7103

PERFORMER ORGANIZATION: Center for Drug Evaluation and Research, FDA, Rockville MD

PROJECTED DATE OF COMPLETION: 10/1/00