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HE 20.4702:C 73
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Guidance for industry M4, the CTD, efficacy questions and answers |
1 |
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HE 20.4702:C 73/2
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Guidance for industry M4, the CTD, general questions and answers |
1 |
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HE 20.4702:C 73/3
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Guidance for industry M4E, the CTD, efficacy |
1 |
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HE 20.4702:C 73/4
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Guidance for industry M4Q, the CTD, quality |
1 |
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HE 20.4702:C 73/5
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Guidance for industry M4S, the CTD, safety |
1 |
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HE 20.4702:C 73/6/DRAFT
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Guidance for industry comparability protocols, chemistry, manufacturing, and controls information |
1 |
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HE 20.4702:C 74
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Guidance for industry E 10 choice of control group and related issues in clinical trials |
1 |
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HE 20.4702:C 76
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Guidance for industry E 10 choice of control group and related issues in clinical trials |
1 |
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HE 20.4702:C 81
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Guidance topical dermatologic corticosteroids, in vivo bioequivalence |
1 |
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HE 20.4702:CL 61
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Visita radial a ClinicalTrials.gov preguntas y respuestas |
1 |
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HE 20.4702:D 26
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Revision of the ICH guideline on clinical safety data management data elements for transmission of individual case safety reports |
1 |
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HE 20.4702:D 26/2
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Guidance for industry E2B(M), data elements for transmission of individual case study reports, questions and answers |
1 |
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HE 20.4702:D 26/3
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Guidance for industry E2BM data elements for transmission of individual case safety reports |
1 |
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HE 20.4702:D 26/4
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Guidance for industry addendum to E2C clinical safety data management : periodic safety update reports for marketed drugs |
1 |
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HE 20.4702:D 54
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Diabetes |
1 |
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HE 20.4702:D 54/2
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Tarjeta de alerta de diabetes diabetes alert |
1 |
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HE 20.4702:D 54/SPAN
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La diabetes salud de la mujer |
1 |
|
HE 20.4702:D 63
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Guidance for industry formal dispute resolution : scientific and technical issues related to pharmaceutical CGMP |
1 |
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HE 20.4702:D 63/2
|
Guidance for industry formal dispute resolution, appeals above the division level |
1 |
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HE 20.4702:D 63/3
|
Guidance for industry dissolution testing of immediate release solid oral dosage forms |
1 |