Withdrawal of Six Guidances on the Clinical Evaluation or Requirements for Approval of Certain Classes of Drugs

概要

The Food and Drug Administration (FDA) is announcing the withdrawal of six guidances on the clinical evaluation or the requirements for approval of radiopharmaceuticals, antacids, antidiarrheals, laxatives, gastric secretory depressants, and drugs to treat superficial bladder cancer. The guidances are being withdrawn because they are out of date and of little use to the drug industry. The agency has developed other guidances and/or resources to assist the industry in obtaining information on the clinical evaluation and the requirements for approval of these classes of drugs.