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  2. Pregnancy category - Wikipedia

    en.wikipedia.org/wiki/Pregnancy_category

    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".

  3. Investigator's brochure - Wikipedia

    en.wikipedia.org/wiki/Investigator's_brochure

    Code of Federal Regulations, Title 21, Part 312, Investigational New Drug Application ; Code of Federal Regulations, Title 21, Part 201.56 (and Part 201.57) CDER Guidance for Industry. Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format. CDER Guidance for Industry.

  4. Affordable Care Act - Wikipedia

    en.wikipedia.org/wiki/Affordable_Care_Act

    Studies focusing on cancer treatment after DCE found a 12.8 percentage point increase in the receipt of fertility-sparing treatment among cervical cancer patients aged 21–25 and an overall increase of 13.4 percentage points compared to those aged 26–34, as well as an increased likelihood that patients aged 19–25 with stage IIB-IIIC ...