A bill to amend the Federal Food, Drug, and Cosmetic Act to require the generic labeling of drugs and the disclosure to drug users of side effects, adverse reactions, and related information; to strengthen the records and reports authority under that act; to require the reporting of information respecting significant health hazards to authorize conditional approval of new drugs; to strengthen the Food and Drug Administration.

[AI summary unavailable — showing source text] Title I: Drug Safety Amendments - Drug Safety Amendments - Requires, under the Federal Food, Drug, and Cosmetic Act, the insertion on packages of any drug which may be sold only upon prescription, the name and place of business of the manufacturer of the final dosage form of the drug and, if different, the name and place of business of the packer or distributor and, in the case of any other drug or device, the name and place of business of the manufacturer, packer, or distributor. Requires reports on, and record-keeping pertaining to, clinical and preclinical investigation of drugs or substances intended for use as a drug. Provides that if the Secretary of Health, Education, and Welfare determines that any information obtained or received by him reasonably supports a conclusion that such a drug introduced for commercial distribution may present a significant hazard to human health, or may cause cancer in animals, he shall mail or cause to be mailed to all practitioners licensed by law to administer drugs, a summary of such information. Provides for the conditional approval of new drugs by the Secretary. Authorizes the Secretary to immediately suspend approval of a drug application …