21 CFR 514.5 - Presubmission conferences
| Cite as | 21 CFR 514.5 |
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12 practice notes
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Agency information collection activities; proposals, submissions, and approvals,
...technology. Presubmission Conferences, New Animal Drug Applications and Supporting Regulations and Guidance 152, and Form FDA 356V--21 CFR 514.5, 514.1, 514.4, 514.8, (OMB Control Numbers 0910-0555, 0910-0032, 0910-0356, 0910-0522, and Under section 512(b)(3) of the Federal Food, Drug, and ......
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Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With New Animal Drug Applications
...512(j) of the FD&C Act is entitled to one or more conferences with us prior to making a submission. Section 514.5 of our regulations (21 CFR 514.5) describes the procedures for requesting, conducting, and documenting pre-submission conferences. We have found that these meetings have inc......
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Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug Applications and Supporting Regulations, and Form FDA 356V
...technology. Presubmission Conferences, New Animal Drug Applications and Supporting Regulations and Guidance 152, and Form FDA 356V--21 CFR 514.5, 514.1, 514.4, and 514.8 (OMB Control Number Under section 512(b)(3) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360......
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Agency information collection activities; proposals, submissions, and approvals,
...Control Number--(0910-0452)--Extension CVM holds meetings and/or teleconferences when a sponsor requests a presubmission conference under 21 CFR 514.5, or requests a meeting to discuss general questions. Generally, meeting requests are submitted to CVM on paper. However, CVM now allows regi......
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