Prescribing information: difference between revisions
Diff·revision 4 → 5·14:13, 24 Oct 2024
Difference between revision 4 and revision 5 of Prescribing information. 3 lines changed; the page grew by 270 bytes.
| Revision 4 — 11:26, 4 Oct 2024 Peptide_Pete (talk) attribute the survey figure to the survey and give its sample size 2,203 bytes +272 | Revision 5 — 14:13, 24 Oct 2024 SarcopeniaSefa (talk) rm the projection; nothing cited supports it 2,473 bytes +270 | ||
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| 10 | It is a regulated document rather than a manufacturer's description. Its content is negotiated with the regulator and changes require approval, which is why it is a more reliable source than promotional material and why it lags the literature.{{r|fda_labeling}} | 10 | It is a regulated document rather than a manufacturer's description. Its content is negotiated with the regulator and changes require approval, which is why it is a more reliable source than promotional material and why it lags the literature.{{r|fda_labeling}} |
| 11 | 11 | ||
| + | 12 | It is jurisdiction-specific. The same product may carry different indications, different populations and different warnings in different countries, so the label of one jurisdiction does not describe the product in another.{{r|ema_smpc}} | |
| + | 13 | ||
| 12 | == Structure == | 14 | == Structure == |
| 13 | Labelling follows a prescribed structure so that the same information is in the same place across products: indications, dosage and administration, dosage forms, contraindications, warnings and precautions, adverse reactions, drug interactions, use in specific populations, description, clinical pharmacology, non-clinical toxicology, clinical studies, and storage.{{r|fda_labeling}} | 15 | Labelling follows a prescribed structure so that the same information is in the same place across products: indications, dosage and administration, dosage forms, contraindications, warnings and precautions, adverse reactions, drug interactions, use in specific populations, description, clinical pharmacology, non-clinical toxicology, clinical studies, and storage.{{r|fda_labeling}} |
| ⋮ | ⋮ | ||
| 25 | [[Category:Prescribing and telehealth]] | 27 | [[Category:Prescribing and telehealth]] |
| 26 | [[Category:Drug regulation]] | 28 | [[Category:Drug regulation]] |
| + | 29 | [[Category:Regulation and law]] | |
| 27 | 30 |