Regulations.gov document
56. FDA-2012-P-0895-0014 re Request FDA uniformly apply its standards for permitting a…
Supporting & Related Material · FDA-2016-P-0645 · posted Mar 9, 2016
Key facts
| Document ID | FDA-2016-P-0645-0010 |
|---|---|
| Title | 56. FDA-2012-P-0895-0014 re Request FDA uniformly apply its standards for permitting a drug to be labeled as abuse deterrent y (a) requiring pre-marketing scientific proof of manipulation and extraction studies for abuse deterrent formulation in both small and large volume extraction |
| Document type | Supporting & Related Material |
| Subtype | Background Material |
| Agency | FDA |
| Docket | FDA-2016-P-0645 |
| Posted | Mar 9, 2016 |
At a glance
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