Call Number (LC) Title Results
HE 20.4702:C 17/3/DRAFT Guidance for industry statistical aspects of the design, analysis, and interpretation of chronic rodent carcinogenicity studies of pharmaceuticals. 1
HE 20.4702:C 33 Manual del Centro para la Evaluacion e Investigacion de Farmacos 1
HE 20.4702:C 33/2 Guidance for sponsors, industry, researchers, investigators, and Food and Drug Administration staff certifications to accompany drug, biological product and device applications/submissions : compliance with Section 402(j) of the Public Health Service Act, added by Title VIII of the Food and Drug Administration Amendments Act of 2007. 1
HE 20.4702:C 42 Guidance for industry format and content for the CMC section of an annual report. 1
HE 20.4702:C 43 Cómo darles la medicina a los niños 1
HE 20.4702:C 46 Reviewer guidance validation of chromatographic methods. 1
HE 20.4702:C 61 Guidance for industry E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. 1
HE 20.4702:C 61/2 Guidance for industry E 11 clinical investigation of medicinal products in the pediatric population. 1
HE 20.4702:C 61/3 Guidance for industry E6 good clinical practice, consolidated guidance. 1
HE 20.4702:C 61/4 Guidance for industry acceptance of foreign clinical studies. 1
HE 20.4702:C 61/5 Reviewer guidance conducting a clinical safety review of a new product application and preparing a report on the review. 1
HE 20.4702:C 61/6 Guidance for industry E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs, questions and answers. 1
HE 20.4702:C 62 Guidance for industry clozapine tables, in vivo bioequivalence and in vitro dissolution testing. 1
HE 20.4702:C 62/2 Guidance for industry container closure systems for packaging human drugs and biologics. 1
HE 20.4702:C 62/3 Guidance for industry container closure systems for packaging human drugs and biologics, questions and answers. 1
HE 20.4702:C 67 Cómo tratar los resfriados y la influenza 1
HE 20.4702:C 73 Guidance for industry M4, the CTD, efficacy questions and answers. 1
HE 20.4702:C 73/2 Guidance for industry M4, the CTD, general questions and answers. 1
HE 20.4702:C 73/3 Guidance for industry M4E, the CTD, efficacy. 1
HE 20.4702:C 73/4 Guidance for industry M4Q, the CTD, quality. 1