How the FDA Determines the “Safety” of Drugs Does FDA approval of a drug mean that the drug has been approved as safe for general use?
No. The FDA does not approve a prescription or over-the-counter drug as sale for universal (general) use. The FDA approves specific doses of a drug for the treatment of specific conditions or illnesses. If the “Indications” section of the package insert does not specifically mention your condition, then the FDA has not approved the drug as safe and effective for that use. What does “approved as safe by the FDA” really mean? FDA does not guarantee the safety of FDA-approved drugs FDA approval of a drug as safe does not automatically mean that the drug has been subjected to a properly controlled scientific evaluation and follow-up of individuals exposed to the direct and indirect effects of the drug. The Director of the FDA’s Bureau of Drugs has confirmed in writing that the FDA does not guarantee the safety of any drug-not even those drugs which the FDA has officially approved as safe. Dictionary and FDA differ on definition of safe When the FDA does use the term “safe” the agency does
