 | 1992 - 1016 lapas
...tests required varies with the duration and nature of the proposed clinical investigations. Guidelines are available from FDA that describe ways in which...appropriate, with additional information pertinent to safety. Food and Drug Administration, HHS (i) Pharmacology and drug disposition. A section describing the pharmacological... | |
 | 1998 - 1120 lapas
...tests required varies with the duration and nature of the proposed clinical Investigations. Guidelines are available from FDA that describe ways in which...appropriate, with additional information pertinent to safety. (1) Pharmacology and drug disposition. A section describing the pharmacological effects and mechanlsm(s)... | |
 | United States. Congress. House. Committee on Government Operations - 1964 - 844 lapas
...results and concluded that it is reasonably safe to initiate clinical investigations with the drag and a statement of where the investigations were conducted...and where the records are available for inspection ; and enough details about the Investigations to permit scientific review. The preclinical investigations... | |
 | United States. Congress. Senate. Judiciary - 1969 - 1222 lapas
...results and concluded that it is reasonably safe to initiate clinical investigations with the drug and a statement of where the investigations were conducted...and where the records are available for inspection; and enough details about the investigations to permit scientific review. The preclinical investigations... | |
 | 1976 - 1046 lapas
...results and concluded that It Is reasonably safe to Initiate clinical Investigations with the drug and a statement of where the Investigations were conducted...and where the records are available for Inspection; and enough details about the Investigations to permit scientific review. The precllnlcal Investigations... | |
| |
Such information should include identification of the person who conducted each investigation; identification and qualifications of the individuals who evaluated the results and concluded that it is reasonably safe to initiate clinical... 
