level: Regulatory Process
Questions and Answers List
level questions: Regulatory Process
| Question | Answer |
|---|---|
| The Regulatory Process concern was poisonous or addictive, not with efficacy and possible harmful effects | Mid-19th century ( 1906 Food and Drugs Act) |
| The Regulatory Process safety must be demonstrated, inspection of manufacturing facilities | 1937 - Diethylene glycol in sulfonamide cause 107 deaths in USA |
| The Regulatory Process proven efficacy and safety | 1962: Kefauver-Harris amendment |
| Thalidomide tragedy- Europe | 1960 |
| all new drugs has to be submitted for approval before clinical trials could begin, and before they can proceed to market | 1963: Committee on the Safety of Drugs |
| illegal to proceed with trials without approval | 1968: Medicines Act |
| evidence of efficacy was added to the criteria; evidence of safety, efficacy and chemical purity | 1970 |