Office of Infectious Diseases (OID) - Division of Pharmacology/Toxicology for Infectious Diseases (DPTID)

The role of the Pharmacology and Toxicology discipline is to help assure the safety of new drugs. Pharmacology and Toxicology review staff evaluate nonclinical data to aid in selecting safe starting and maximum doses for “first in human” clinical trials and direct attention to potential toxicities that should be monitored in the clinic. Pharmacology and Toxicology reviewers also assess toxicities that cannot be addressed in clinical trials such as potential for carcinogenicity, teratogenicity, mutagenicity and chronic toxicity.  Drug impurities, nitrosamines, and leachables and extractables from container closure systems and packaging, are also evaluated during product safety review.

Resources:

• Guidances: For DPTID specific and/or relevant guidance documents (draft or final)
• Advisory Committee Meetings: Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee)
• Public Meetings (Upcoming and Past)