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January 12, 2021
Importing Personal Protective Equipment into Australia during the COVID-19 Pandemic

Importing Personal Protective Equipment into Australia during the COVID-19 Pandemic

Posted January 12, 2021 | By Pallab Roy An increased […]
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January 4, 2021
HSA, Singapore Updates Guidance on Therapeutic Product Registration and Related Appendices

Health Science Authority (HSA), Singapore Updates Guidance on Therapeutic Product Registration and Related Appendices

Posted January 04, 2021 | By Pallab Roy As part […]
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December 28, 2020
TGA Issues Guidance on eCTD Baseline Sequences

TGA Issues Guidance on eCTD Baseline Sequences

Posted December 28, 2020 | By Pallab Roy On November […]
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December 18, 2020
Guidance on Controlled Correspondence Related to Generic Product Development

USFDA Finalizes Guidance on Controlled Correspondence Related to Generic Drug Development

Posted December 18, 2020 | By Pallab Roy On December […]
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November 25, 2020
USFDA Finalizes Guidance on Formal Meetings with the Agency for Complex Products

USFDA Finalizes Guidance on Formal Meetings with the Agency for Complex Products

Posted November 25, 2020 | By Pallab Roy On November […]
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October 16, 2020
TGA Launches Early Scientific Advice Service

TGA Launches Early Scientific Advice Service

Posted October 16, 2020 | By Pallab Roy On September […]
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October 8, 2020

USFDA Finalizes Guidance on Amendments and Requests for Final Approval to Tentatively Approved ANDAs

Posted October 08, 2020 | By Pallab Roy On September […]
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September 30, 2020
Selection of Comparator Products for Use in BE Studies

MHRA Releases Post-transition Period Guidance on Selection of Comparator Products in BE/ TE Studies

Posted September 30, 2020 | By Pallab Roy The UK […]
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September 29, 2020
Guidance to Assist Applicants Respond to an ANDA CRL

USFDA Issues Draft Guidance to Assist Applicants Respond to an ANDA CRL

Posted September 29, 2020 | By Pallab Roy Yesterday, the […]
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September 16, 2020
USFDA Issues Draft Guidance on Geriatric Information in Product Labeling

USFDA Issues Draft Guidance on Geriatric Information in Product Labeling

Posted September 16, 2020 | By Pallab Roy Yesterday, the […]
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