Drugs -- United States -- Testing
Label
Drugs -- United States -- Testing
Name
Drugs
Focus
Sub focus
Actions
Incoming Resources
- Subject of19
- Guideline for the format and content of the nonclinical pharmacology/toxicology section of an application
- Prescription drugs, many factors affected FDA's approval of selected "pipeline" drugs : report to congressional requesters
- Guidance for industry and review staff, nonclinical safety evaluation of reformulated drug products and products intended for administration by an alternate route
- Reviewer guidance, integration of study results to assess concerns about human reproductive and developmental toxicities
- From test tube to patient, improving health through human drugs, Marcia L. Trenter, editor
- Guidance for industry, nonclinical safety evaluation of pediatric drug products
- 21st century cures, modernizing clinical trials : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, second session, July 9, 2014
- FDA's role in the evaluation of Avandia's safety, hearing before the Committee on Oversight and Government Reform, House of Representatives, One Hundred Tenth Congress, first session, June 6, 2007
- 21st century cures, examining barriers to ongoing evidence development and communication : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, second session, July 22, 2014
- Drug user fees, enhancing patient access and drug safety : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining enhancing patient access and drug safety relating to prescription drug user fees, including S. 484, March 14, 2007
- FDA review times, statement of Mary R. Hamilton, Director of Program Evaluation in Human Services Areas, Program Evaluation and Methodology Division, before the Subcommittee on Health and Environment, Committee on Commerce, House of Representatives, United States General Accounting Office
- Guidance for industry, preparation of IDEs and INDs for products intended to repair or replace knee cartilage
- Evaluating the effectiveness of the Food And Drug Administration Modernization Act, hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Seventh Congress, first session, May 3, 2001
- AIDS drugs, where are they? : seventy-third report, by the Committee on Government Operations together with additional views
- Guidance for industry, nonclinical safety evaluation of drug or biologic combinations
- Guidance for industry, providing regulatory submissions to CBER in electronic format, investigational new drug applications (INDs)
- Guidance for industry, photosafety testing
- Guidance for industry, statistical aspects of the design, analysis, and interpretation of chronic rodent carcinogenicity studies of pharmaceuticals
- The professional guinea pig, big pharma and the risky world of human subjects, Roberto Abadie
Outgoing Resources
- Focus1
- Sub focus2