Regulatory Developments January 2020

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Learn about recent draft and final guidances, including smallpox treatments, Hepatitis D treatments, and IND safety reports.


Topic Guidance Status Date

Clinical / Antimicrobial

User Fees
Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention (PDF - 120KB) Final 11/15/2019
Clinical / Antimicrobial Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry Draft 10/31/2019
Electronic Submissions Providing Regulatory Submissions in Electronic Format: IND Safety Reports: Guidance for Industry Draft 10/29/2019
Electronic Submissions Electronic Submission of IND Safety Reports Technical Conformance Guide Final 10/29/2019





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If you or your AAPS Community would like to submit comments, please contact Maria Nadeau, senior member groups manager. She will coordinate your input on behalf of AAPS.

Table of Contents
Regulatory Developments
January 2020

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