Drug master file: difference between revisions
Diff·revision 13 → 14·15:17, 17 Apr 2025
Difference between revision 13 and revision 14 of Drug master file. 2 lines changed; the page grew by 132 bytes.
| Revision 13 — 15:09, 29 Mar 2025 FiveOhThreeB (talk) add the note that this wiki does not give legal advice 3,180 bytes ±0 | Revision 14 — 15:17, 17 Apr 2025 StateBoardStace (talk) name the regulator rather than writing "the authorities" 3,312 bytes +132 | ||
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| 31 | The last row matters here. A DMF describes a process and its controls for a substance intended as an [[Active pharmaceutical ingredient|active pharmaceutical ingredient]]. Material sold as a research chemical is not that substance in the regulatory sense, even where the chemistry is identical.{{r|ich_q7}} | 31 | The last row matters here. A DMF describes a process and its controls for a substance intended as an [[Active pharmaceutical ingredient|active pharmaceutical ingredient]]. Material sold as a research chemical is not that substance in the regulatory sense, even where the chemistry is identical.{{r|ich_q7}} |
| 32 | 32 | ||
| + | 33 | DMF numbers are published in regulator lists, so the existence of a filing is checkable. Its status generally is not.{{r|fda_dmf}} | |
| + | 34 | ||
| 33 | == References == | 35 | == References == |
| 34 | {{reflist}} | 36 | {{reflist}} |