What is required for a drug to be approved by CDER?
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.
