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Hello,  Based on my experience managing ex-US PIs who is not willing to sign FDA form 1572, sponsor must obtain a 1572 Waiver Request granted letter from FDA in order to provide FDA with equivalent form to 1572. This form called Attestation Form signed by PI which must follow same GCP practice and principals. ...

Hello,  Questions: 1.) If one submits a single DSUR for an active substance and there are multiple IND's that utilize the same active substance, how does one determine the "DIBD" and "data lock point" for the multiple IND's? Is it determined based on the primary IND? data based on primary IND, ...

Hello,  Please see some input below.  Form 1572 must be signed before an investigator may begin participation in a clinical study conducted under the IND regulations. The investigator should sign this form only AFTER having been given enough information to be informed about the study and ...

Hello,  Glad to hear FDA took preventative action about nicotine control.  FDA launches new, comprehensive campaign to warn kids about the dangers of e-cigarette use as part of agency's Youth Tobacco Prevention Plan, amid evidence of sharply rising use among kids Fda remove preview

Hello,  I am looking for some guidance transitioning our CTA from paper to eCTD in Health Canada. I realized HC is two years behind then FDA on eCTD  mandate. HC is currently encouraging sponsors to participate in their eCTD Pilot program. Has anyone experience been in the pilot program with HC? ...