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This ruling has removed the requirement of stating pregnancy categories in prescription drug labels. [99] Australia's categorization system takes into account birth defects, the effects around birth or when the mother gives birth, and problems that will arise later in the child's life due to the drug taken. The system places them into a ...
American law requires that certain drugs and biological products must be labelled very specifically. Title 21, Part 201.57 (9)(i) of the Code of Federal Regulations lists specific requirements regarding the labeling of drugs with respect to their effects on pregnant populations, including a definition of a "pregnancy category".
Feet of a baby born to a mother who had taken thalidomide while pregnant. In the late 1950s and early 1960s, the use of thalidomide in 46 countries was prescribed to women who were pregnant or who subsequently became pregnant, and consequently resulted in the "biggest anthropogenic medical disaster ever," with more than 10,000 children born with a range of severe deformities, such as ...
The Australian Drug Evaluation Committee (ADEC) was a committee that provided independent scientific advice to the Australian Government regarding therapeutic drugs.The committee was originally formed in 1963 and more recently authorised under the Therapeutic Goods Act 1989 (Cth) as part of the Therapeutic Goods Administration (TGA).
1.1 Australia (AU) 1.2 Pregnancy category in general. 1.3 ... 2 See also. Toggle the table of contents. Template: Infobox drug/pregnancy category/doc. Add languages ...
Instituted in April 2002, SMART aimed to eliminate isotretinoin-induced birth defects by preventing exposure to the drug during pregnancy. The program mandated two consecutive negative pregnancy tests, birth defect risk counseling and a pledge to use two forms of contraception when engaging in intercourse for all people assigned female at birth ...
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Schedule 8 (S8) drugs and poisons, otherwise known as Controlled Drugs, are schedule 9 prohibited substances that are appropriate preparations for therapeutic use which have high potential for abuse and addiction. The possession of these medications without authority is the same as carrying a prohibited substance and is illegal.