| Health / Medical Topics |
Original Regulatory Submission
Submission of original promotional materials. Includes 2253 submissions, requests for advisory on launch materials, requests for advisory on non-launch materials, pre-submission of promotional materials for accelerated approval products, and materials submitted pursuant to 503B. (Food and Drug Administration)
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The amount, including units, of something as first specified.
A new, unused single-use device.
For INDs, this represents the study(ies) being conducted. For NDAs, ANDAs, and BLAs, this represents the original indication(s) for which approval/licensing is…
Preceding all others in time or being as first made or performed.
Origin recognition complex subunit 6 (252 aa, ~28 kDa) is encoded by the human ORC6 gene. This protein is involved in the…
Origin recognition complex subunit 5 (435 aa, ~50 kDa) is encoded by the human ORC5 gene. This protein plays a role in…
