LIFE SCIENCE

Detailed explanation-1: -The main consumer watchdog in this system is FDA’s Center for Drug Evaluation and Research (CDER). The center’s best-known job is to evaluate new drugs before they can be sold.

Detailed explanation-2: -Drugs are tested on people to make sure they are safe and effective. FDA review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it. FDA monitors all drug and device safety once products are available for use by the public.

Detailed explanation-3: -FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and good clinical practice (GCP) regulations.

Detailed explanation-4: -Who We Are. The Office of Pharmaceutical Quality’s (OPQ) mission is to assure that quality medicines are available for the American public. OPQ integrates assessment, inspection, surveillance, policy, and research activities to strengthen pharmaceutical quality on a global scale.

Detailed explanation-5: -The scope of FDA’s regulatory authority is very broad. FDA’s responsibilities are closely related to those of several other government agencies.