Food and Drug Administration (FDA)

Centers for Disease Control and Prevention (CDC)

National Institutes of Health (NIH)

Environmental Protection Agency (EPA)

To promote innovation and development of new drugs

To protect public health and safety

To ensure fair competition in the pharmaceutical market

To generate revenue for the government

Food, Drug, and Cosmetic Act (FD&C Act)

Public Health Service Act

Controlled Substances Act

Medicare Prescription Drug, Improvement, and Modernization Act

Investigational New Drug (IND) application

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Biologics License Application (BLA)

To allow researchers to conduct clinical trials on a new drug

To request marketing approval for a new drug

To obtain a patent for a new drug

To register a new drug with the FDA

Submitting an NDA to the FDA

Submitting an ANDA to the FDA

Submitting a BLA to the FDA

Submitting a petition to the FDA

To provide incentives for the development of generic drugs

To streamline the drug approval process

To increase funding for the FDA

To establish a national drug formulary

To provide expert advice to the FDA on drug safety and efficacy

To conduct clinical trials on new drugs

To review and approve drug applications

To set drug prices

To assess the safety of drugs after they are marketed

To develop educational materials for healthcare professionals and patients

To implement risk management plans for drugs with serious safety concerns

To conduct post-marketing surveillance studies

To collect reports of adverse events associated with drugs

To investigate adverse events and determine their cause

To take regulatory action against drug manufacturers

To provide information to healthcare professionals and patients about drug safety

To provide incentives for the development of drugs for rare diseases

To conduct clinical trials on orphan drugs

To review and approve orphan drug applications

To set prices for orphan drugs

To require drug manufacturers to conduct pediatric studies on new drugs

To provide funding for pediatric research

To establish a pediatric formulary

To create a pediatric advisory committee

To review and approve new drug applications

To conduct clinical trials on new drugs

To inspect drug manufacturing facilities

To enforce drug regulations

To review and approve new biologics applications

To conduct clinical trials on new biologics

To inspect biologics manufacturing facilities

To enforce biologics regulations

To review and approve new medical devices

To conduct clinical trials on new medical devices

To inspect medical device manufacturing facilities

To enforce medical device regulations