Template:FDA history table: Difference between revisions
From Embryology
(Created page with "{| ! Date ! Events |- | 1906 | Food and Drugs Act is passed by Congress and prohibits interstate transportation of misbranded or adulterated foods, drinks, and drugs. |- | 192...") |
mNo edit summary |
||
| (6 intermediate revisions by the same user not shown) | |||
| Line 1: | Line 1: | ||
{| | {| | ||
! Date | ! colspan=2|US FDA Historic Background | ||
! Events | |-bgcolor="CEDFF2" | ||
! width=100px|Date | |||
! width=600px|Events | |||
|- | |- | ||
| 1906 | | 1906 | ||
| Food and Drugs Act is passed by Congress and prohibits interstate transportation of misbranded or adulterated foods, drinks, and drugs. | | Food and Drugs Act is passed by Congress and prohibits interstate transportation of misbranded or adulterated foods, drinks, and drugs. | ||
|- | |-bgcolor="F5FAFF" | ||
| 1927 | | 1927 | ||
| Food and Drug Administration Agency is formed and given authority to enforce the Food and Drugs Act. | | Food and Drug Administration Agency is formed and given authority to enforce the Food and Drugs Act. | ||
| Line 11: | Line 13: | ||
| 1938 | | 1938 | ||
| Federal Food, Drug, and Cosmetic (FDC) Act is passed, requiring all drugs to have demonstrated safety prior to marketing. | | Federal Food, Drug, and Cosmetic (FDC) Act is passed, requiring all drugs to have demonstrated safety prior to marketing. | ||
|- | |-bgcolor="F5FAFF" | ||
| 1951 | | 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. | | 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. | ||
| Line 17: | Line 19: | ||
| 1962 | | 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. | | 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. | ||
|- | |-bgcolor="F5FAFF" | ||
| 1966 | | 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. | | 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. | ||
| Line 23: | Line 25: | ||
| 1970 | | 1970 | ||
| FDA requires first package insert for women using oral contraceptives. | | FDA requires first package insert for women using oral contraceptives. | ||
|- | |-bgcolor="F5FAFF" | ||
| 1979 | | 1979 | ||
| As published in 1980, FDA establishes the ABCDX pregnancy risk categories and requires the packaging label to include one of these categories. | | As published in 1980, FDA establishes the ABCDX pregnancy risk categories and requires the packaging label to include one of these categories. | ||
| Line 29: | Line 31: | ||
| 1993 | | 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. | | 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. | ||
|- | |-bgcolor="F5FAFF" | ||
| 2007 | | 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. | | 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. | ||
| Line 35: | Line 37: | ||
| 2008 | | 2008 | ||
| FDA proposes changing the pregnancy labeling categories. | | FDA proposes changing the pregnancy labeling categories. | ||
|- | |-bgcolor="F5FAFF" | ||
| 2015 | | 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. | | 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. | ||
|- | |- | ||
| colspan=2|Table historic data{{#pmid:28556499|PMID28556499} | | colspan=2|Table historic data{{#pmid:28556499|PMID28556499}} | ||
|} | |}<noinclude>[[Category:Template]][[Category:Table]][[Category:Historic Embryology]][[Category:USA]][[Category:Milk]][[Category:Drugs]][[Category:Postnatal]]</noinclude> | ||
Latest revision as of 17:08, 15 February 2018
| 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] | |
