Template:FDA history table

From Embryology
US FDA Historic Background
Date Events
1906 Food and Drugs Act is passed by Congress and prohibits interstate transportation of misbranded or adulterated foods, drinks, and drugs.
1927 Food and Drug Administration Agency is formed and given authority to enforce the Food and Drugs Act.
1938 Federal Food, Drug, and Cosmetic (FDC) Act is passed, requiring all drugs to have demonstrated safety prior to marketing.
1951 Durham-Humphrey Amendment established the category of prescription drugs and gave the FDA the power to determine if a drug should be prescription-only or over-the-counter.
1962 Kefauver-Harris Amendment passed after thalidomide was found to cause birth defects. It requires drug manufacturers to provide stronger evidence of safety and effectiveness prior to FDA approval for marketing.
1966 FDA issued requirement for animal studies referred to as “3-Segment Studies” to evaluate safety of drugs. The studies should be designed to address 1) fertility, 2) in utero development, and 3) perinatal and postnatal effects.
1970 FDA requires first package insert for women using oral contraceptives.
1979 As published in 1980, FDA establishes the ABCDX pregnancy risk categories and requires the packaging label to include one of these categories.
1993 FDA revises a policy that excluded women of childbearing potential from being participants in drug trials and requires improved assessments of medication responses specific to gender.
2007 New regulations are passed that require all studies of drugs that involve human participants to register with ClinicalTrials.gov.; some drugs to conduct postapproval studies or have a risk evaluation and mitigation strategy to monitor the drug once it is marketed; and package inserts to include contact information for reporting adverse reactions.
2008 FDA proposes changing the pregnancy labeling categories.
2015 Content and Format of Labeling for Human Prescription Drug and Biologic Products; Requirements for Pregnancy and Lactation Labeling (Final rule 79, FR 72064) is passed and requires the removal of the ABCDX labels from all prescription and biologic product labels and new requirements to include narrative descriptions.
Table historic data[1]
  1. Brucker MC & King TL. (2017). The 2015 US Food and Drug Administration Pregnancy and Lactation Labeling Rule. J Midwifery Womens Health , 62, 308-316. PMID: 28556499 DOI.