Under current law, all new drugs need proof that they are effective and safe before they can be approved for marketing. No drug is absolutely safe; there is always some risk of an adverse reaction. CDER decides–as quickly as a thorough evaluation allows–whether the studies submitted by the drug’s sponsor (usually the manufacturer) show it to be safe and effective for its intended use. When a proposed drug’s benefits outweigh known risks, CDER considers it safe enough to approve. Once a drug gets CDER approval, the drug is on the market as soon as the firm gets its production and distribution systems going.
