Performance Improvement 2000. Drug Application Review

01/01/2000

Drug Metabolism: Drug-Drug Interactions

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: Collins, Jerry
301-427-1065

PIC ID: 7103

PERFORMER: Food and Drug Administration
Rockville MD

EXPECTED DATE OF COMPLETION: 10/1/2000

Laboratory Support Services for FDA Compliance and Surveillance

This initiative of the human drug program involves multiple evaluative aspects. Two examples are: (1) conducting the hormones surveillance program, and (2) developing analytical methods for drug fingerprinting in the assessment of drug quality. The anticipated outcome of this effort will support the Food and Drug Administration's (FDA's) regulatory actions by providing laboratory support for the agency's compliance and methods development functions. In addition, drug fingerprint profiles will provide forensic assessments of drug manufacturing origin in support of FDA investigational efforts in deterring drug counterfeiting.

AGENCY SPONSOR: Center for Drug Evaluation and Research

FEDERAL CONTACT: Hanig, Joe
301-594-5026

PIC ID: 7107

PERFORMER: Food and Drug Administration
Rockville MD

EXPECTED DATE OF COMPLETION: 9/30/2000

Methods Validation

The objective of this project is to verify the suitability of New Drug Approval (NDA) and Abbreviated New Drug Applications (ANDA) analytical methods for drugs, antibiotics and hormones for quality control and regulatory purposes.

AGENCY SPONSOR: Center for Drug Evaluation and Research

FEDERAL CONTACT: Hanig, Joe
301-594-5026

PIC ID: 7106

PERFORMER: Food and Drug Administration
Rockville MD

EXPECTED DATE OF COMPLETION: 9/30/2000

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

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 with the hope 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: Roberts, Rosemary, Ph.D.
301-827-2183

PIC ID: 6736

PERFORMER: Food and Drug Administration
Rockville MD

EXPECTED DATE OF COMPLETION: 10/1/2000