|
000
| 01948nam 2200313za 4500 |
|---|
| 001 | 9.833169 |
|---|
| 003 | CaOODSP |
|---|
| 005 | 20221107150147 |
|---|
| 007 | cr ||||||||||| |
|---|
| 008 | 170426t20172016onc o f000 0 eng d |
|---|
| 020 | |a978-0-660-07793-2 |
|---|
| 040 | |aCaOODSP|beng |
|---|
| 043 | |an-cn--- |
|---|
| 086 | 1 |aH164-205/2017E-PDF |
|---|
| 245 | 00|aPublic release of clinical information in drug submissions and medical device applications |h[electronic resource] / |cHealth Products and Food Branch. |
|---|
| 260 | |aOttawa : |bHealth Canada, |c2017, c2016. |
|---|
| 300 | |a8 p. |
|---|
| 500 | |aIssued also in French under title: Diffusion publique de renseignements cliniques dans les présentations de médicaments et les demandes d’homologation d’instruments médicaux. |
|---|
| 500 | |aCover title. |
|---|
| 500 | |a"March 10, 2017." |
|---|
| 520 | |a"This document introduces Health Canada’s initiative to publicly release clinical information concerning the safety and efficacy of drugs and safety and effectiveness of medical devices. It sets out the policy objectives, rationale and considerations for future regulations that would specify that certain clinical information contained in drug submissions or medical device applications would not be treated or cease to be confidential business information following a final regulatory decision and that would authorize the public release of that information"--Preface, p. 1. |
|---|
| 692 | 07|2gccst|aDrugs |
|---|
| 692 | 07|2gccst|aMedical products |
|---|
| 692 | 07|2gccst|aFreedom of information |
|---|
| 692 | 07|2gccst|aGovernment policy |
|---|
| 710 | 1 |aCanada. |bHealth Canada. |
|---|
| 710 | 1 |aCanada. |bHealth Products and Food Branch. |
|---|
| 775 | 08|tDiffusion publique de renseignements cliniques dans les présentations de médicaments et les demandes d’homologation d’instruments médicaux |w(CaOODSP)9.833171 |
|---|
| 856 | 40|qPDF|s124 KB|uhttps://publications.gc.ca/collections/collection_2017/sc-hc/H164-205-2017-eng.pdf |
|---|