Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies
2 August 2022 — FDA published draft guidance for industry. Submit comments by 3 October 2022.
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EMA Initiatives for Acceleration of Development Support and Evaluation Procedures for COVID-19 Treatments and Vaccines
3 August 2022 — EMA published guidance on rapid formal review procedures related to COVID-19.
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Complex Generics News
5 August 2022 — FDA published up-to-date information on FDA’s actions on complex generics.
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Decommission of eSUSAR
3 August 2022 — MHRA inspectorate announced decommission of eSUSAR.
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Bioresearch Monitoring Technical Conformance Guide
5 August 2022 — FDA published technical specifications guidance on bioresearch monitoring technical conformance guide.
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