Investigational New Drug Applications; Proposed Amendment to Clinical Hold Regulations for Products Intended for Life-Threatening Diseases
describes the 1977 guideline 'General Considerations for the Clinical Evaluation of Drugs', developed 'within the protective environment brought on by the thalidomide experience a decade earlier', which stated that women of childbearing potential should not be included in phase 1 and early phase 2 trials; and the 1993 guideline (58 FR 39406, 22 July 1993) that revoked the restriction.
describes the 1977 guideline 'General Considerations for the Clinical Evaluation of Drugs', developed 'within the protective environment brought on by the thalidomide experience a decade earlier', which stated that women of childbearing potential should not be included in phase 1 and early phase 2 trials; and the 1993 guideline (58 FR 39406, 22 July 1993) that revoked the restriction.
Written from the full text read 2026-10-15.
What our sources record
Reproduced as it was written when this source was checked, figures and all.
97N-0030. Full text read: describes the 1977 guideline 'General Considerations for the Clinical Evaluation of Drugs', developed 'within the protective environment brought on by the thalidomide experience a decade earlier', which stated that women of childbearing potential should not be included in phase 1 and early phase 2 trials; and the 1993 guideline (58 FR 39406, 22 July 1993) that revoked the restriction.