WebApr 18, 2024 · An inactive IND can be reactivated via a protocol amendment INDs inactive for ≥5 years may be terminated by FDA Termination ( 21 CFR 312.44 ) initiated by FDA If an IND is terminated, the sponsor must end all clinical investigations under the IND and recall or otherwise provide for the disposition of all unused supplies of the drug Webinactive ingredient: Additive, Excipient Clinical pharmacology A substance regarded by the FDA as having no effect on a drug's absorption or metabolism, which is added for …

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Web( b) If an IND is withdrawn, FDA shall be so notified, all clinical investigations conducted under the IND shall be ended, all current investigators notified, and all stocks of the drug returned to the sponsor or otherwise disposed of at the request of the sponsor in accordance with § 312.59. WebIf FDA seeks to act on its own initiative under this section, it shall first notify the sponsor in writing of the proposed inactive status. Upon receipt of such notification, the sponsor … list of themes

CFR - Code of Federal Regulations Title 21 - Food and Drug Administration

WebIf all investigations covered by an IND remain on clinical hold for 1 year or more, the IND may be placed on inactive status by FDA under § 312.45. [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 19477, May 22, 1987; ... WebClinical investigations under an IND on inactive status may only resume 30 days after FDA receives the protocol amendment, unless FDA notifies the sponsor that the investigations described in the amendment are subject to a clinical hold; or on earlier notification by FDA that the investigation may proceed. WebJan 17, 2024 · If FDA seeks to act on its own initiative under this section, it shall first notify the sponsor in writing of the proposed inactive status. Upon receipt of such notification, … immigration lawyers in waco texas