Clinical Hold | PharmaBharat Tools

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Clinical Hold | PharmaBharat Tools

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Abbreviated New Drug Application(ANDA)IND Annual Report Active Substance Master File(ASMF)Biologics License Application(BLA)Center for Drug Evaluation and Research(CDER)Certificate of Suitability(CEP)Clinical Hold Clinical Trial Application(CTA)Drug Master File(DMF)DMF Type II DMF Type III DMF Type IV DMF Type V FDA Form 1571 FDA Form 356h FDA Form 3674 505(b)(2) Application(505(b)(2))Investigational New Drug(IND)Initial Pediatric Study Plan(iPSP)Letter of Authorization(LoA)Marketing Authorisation Application(MAA)New Drug Application(NDA)Orange Book Reference Listed Drug(RLD)Supplement

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RA Regulatory SubmissionsClinical Hold

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Certificate of Suitability (CEP)Clinical Trial Application (CTA)

Clinical Hold

Regulatory Submissions

Definition

An FDA order to delay a proposed clinical investigation or suspend an ongoing investigation under an IND.

Regulatory source

21 CFR 312.42