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USFDA Guidance on Premarket Review of Combination Products

Feb 6, 2022
1 min

USFDA Guidance on Premarket Review of Combination Products

US Food and Drug Administration (FDA) has finalized guidance for industry and agency staff on the use of Principles of Premarket Pathways...

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Swissmedic Guidance on Renewals, Variations & Extensions

Sharan Murugan

Feb 6, 2022
1 min

Swissmedic Guidance on Renewals, Variations & Extensions

On January 28, 2022 Swismedic released a list of guidances for different segments, check out the below important list of swiss medic...

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Ireland's guidance on New Application & Variations, Registartion Requirements,

Sharan Murugan

Feb 6, 2022
2 min

Ireland's guidance on New Application & Variations, Registartion Requirements,

Irelands HPRA released a few guidances in the past week Guide to New Applications and Variations to Manufacturer's Authorisations This...

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Guidance on Revising ANDA Labeling Following Revision of the RLD Labeling

Sharan Murugan

Feb 6, 2022
1 min

Guidance on Revising ANDA Labeling Following Revision of the RLD Labeling

This guidance is intended to assist applicants and holders of an abbreviated new drug application (ANDA) in updating their labeling...

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Patients’ Experiences & Engagements Medical Device Guidances - USFDA

Sharan Murugan

Jan 27, 2022
1 min

Patients’ Experiences & Engagements Medical Device Guidances - USFDA

US FDA issued two medical devices (final guidance documents on January 26, 2022, to help sponsors better incorporate and capture...

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USFDA Guidance update on Generic Drug Application Submissions, Labeling, and Review

Sharan Murugan

Jan 27, 2022
1 min

USFDA Guidance update on Generic Drug Application Submissions, Labeling, and Review

FDA published a series of guidances on January 26, 2022 focussing on Generic Drug Application Submissions, Labeling, and Review. These...

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Electronic Application Form and Cover Letter Tool - UK MHRA

Sharan Murugan

Jan 23, 2022
1 min

Electronic Application Form and Cover Letter Tool - UK MHRA

On January 20, 2022, the UK MHRA released guidance on how to complete your Electronic Application Form (eAF) and Cover Letter. This form...

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CHINA’S NMPA: Development Guideline of Drug-Device Combinations

Sharan Murugan

Jan 23, 2022
2 min

CHINA’S NMPA: Development Guideline of Drug-Device Combinations

China’s National Medical Products Administration (NMPA) released 2 guidelines supporting the development and registration of drug-device...

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India's National Pharmaceutical Pricing Authority (NPPA) -Study on global drug pricing policies

Sharan Murugan

Jan 23, 2022
1 min

India's National Pharmaceutical Pricing Authority (NPPA) -Study on global drug pricing policies

National Pharmaceutical Pricing Authority (NPPA) was established through a Government of India Resolution dated 29th August, 1997 as an...

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EMA Guidance for Applicants seeking Scientific Advice and Protocol Assistance

Sharan Murugan

Jan 16, 2022
1 min

EMA Guidance for Applicants seeking Scientific Advice and Protocol Assistance

This guidance document addresses a number of questions that users of the scientific advice or protocol assistance procedures may have and...

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UK Guidance on Clinical Trials: How to Apply for Authorization

Sharan Murugan

Jan 16, 2022
1 min

UK Guidance on Clinical Trials: How to Apply for Authorization

UK MHRA updated its guidance on How to apply for a clinical trial including eligibility, phases, model IMPDs, costs, and how to make...

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Guidelines for Biowaiver -Saudi Food & Drug Authority SFDA

Sharan Murugan

Jan 16, 2022
1 min

Guidelines for Biowaiver -Saudi Food & Drug Authority SFDA

SFDA updated their Biowaiver guideline recently. These guidelines are intended to facilitate and support the workflow of drug...

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Regulating Medical Devices & Place on The Market – UK

Sharan Murugan

Jan 7, 2022
1 min

Regulating Medical Devices & Place on The Market – UK

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. This guide...

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