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South Africa SAHPRA: eCTD Validation and Technical Screening for Renewals - Template

2 days ago
2 min

South Africa SAHPRA: eCTD Validation and Technical Screening for Renewals - Template

The South African Health Products Regulatory Authority (SAHPRA) has provided updated guidance for " ECTD Validation And Technical...

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USFDA Guidance: Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle

Sharan Murugan

4 days ago
2 min

USFDA Guidance: Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle

USFDA's Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) released a draft...

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USFDA Guidance: Control of Nitrosamine Impurities in Human Drugs

Sharan Murugan

7 days ago
2 min

USFDA Guidance: Control of Nitrosamine Impurities in Human Drugs

Earlier today (04 September, 2024) U.S. Food and Drug Administration's Center for Drug Evaluation and Research released the second...

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USFDA Guidance: Bioresearch Monitoring Technical Conformance Guide

Sharan Murugan

Sep 3
2 min

USFDA Guidance: Bioresearch Monitoring Technical Conformance Guide

The USFDA Center for Drug Evaluation and Research issued the final guidance today (03 September 2024) " Bioresearch Monitoring...

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Swissmedic Guidance: The Electronic Exchange of ICSRs in E2B(R3) Format through PV Gateway

Sharan Murugan

Sep 1
2 min

Swissmedic Guidance: The Electronic Exchange of ICSRs in E2B(R3) Format through PV Gateway

The Swissmedic released an updated guidance " Electronic Exchange of ICSRs in E2B(R2) Format through PV Gateway " that provides...

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USFDA Guidance: Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers

Sharan Murugan

Aug 31
2 min

USFDA Guidance: Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers

The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research and Center for Devices and Radiological Health ...

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India's: Newly Launched Indian Pharmacopoeia (IP) Online Portal and Adverse Drug Monitoring System (ADRMS) Online Portal

Sharan Murugan

Aug 27
2 min

India's: Newly Launched Indian Pharmacopoeia (IP) Online Portal and Adverse Drug Monitoring System (ADRMS) Online Portal

India has recently made significant advancements in its healthcare regulatory landscape by launching two new online portals " Adverse...

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UK MHRA Guidance: Clinical Trials for Medicines – Applying for Authorisation in the UK

Sharan Murugan

Aug 27
2 min

UK MHRA Guidance: Clinical Trials for Medicines – Applying for Authorisation in the UK

The UK Medicines and Healthcare products Regulatory Agency (MHRA) updated their comprehensive guidance " Clinical Trials for Medicines –...

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Swissmedic Guidance: The Electronic Exchange of ICSRs in E2B(R3) Format Through B2B Gateway

Sharan Murugan

Aug 26
2 min

Swissmedic Guidance: The Electronic Exchange of ICSRs in E2B(R3) Format Through B2B Gateway

Today (26 August, 2024) the Swissmedic released " guidance for the industry on the electronic exchange of ICSRs in E2B(R3) format...

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USFDA Guidance: Electronic Submissions for De Novo Requests and Section 513(g) Requests for Information

Sharan Murugan

Aug 24
2 min

USFDA Guidance: Electronic Submissions for De Novo Requests and Section 513(g) Requests for Information

Yesterday the U.S. Food and Drug Administration (FDA) has released critical guidance documents to streamline the regulatory pathways for...

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USFDA Guidance: Predetermined Change Control Plans for Medical Devices

Sharan Murugan

Aug 24
2 min

USFDA Guidance: Predetermined Change Control Plans for Medical Devices

The U.S. Food and Drug Administration (FDA) has released a guidance document titled " Predetermined Change Control Plans for Medical...

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India CDSCO Guidance: Draft Pharmaceutical Good Distribution Practices (GDP)

Sharan Murugan

Aug 20
2 min

India CDSCO Guidance: Draft Pharmaceutical Good Distribution Practices (GDP)

The Central Drugs Standard Control Organisation (CDSCO) in India has issued a draft guideline on Good Distribution Practices (GDP) for...

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USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA

Sharan Murugan

Aug 19
2 min

USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA

The U.S. Food and Drug Administration (FDA) on August 19, 2024, published the guidance “ Product-Specific Guidance Meetings Between FDA...

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UK MHRA Guidance: Apply for the Early Access to Medicines Scheme (EAMS)

Sharan Murugan

Aug 18
2 min

UK MHRA Guidance: Apply for the Early Access to Medicines Scheme (EAMS)

The Medicines and Healthcare Products Regulatory Agency (MHRA) published guidance on "Apply for the early access to medicines scheme...

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UK MHRA Guidance: Medicines Pipeline Data and Pre-submission Advice & Support

Sharan Murugan

Aug 15
2 min

UK MHRA Guidance: Medicines Pipeline Data and Pre-submission Advice & Support

The Medicines and Healthcare Products Regulatory Agency (MHRA) published a guidance on " Medicines Pipeline Data " on 13 August, 2024 to...

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USFDA Guidance: Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases

Sharan Murugan

Aug 11
2 min

USFDA Guidance: Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases

Last Thursday (08 August 2024) the U.S. Food and Drug Administration (FDA) released final guidance aimed at " Optimizing the Dosage of...

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Swiss Medic: Guidance on Packaging for Human Medicinal Products

Sharan Murugan

Aug 3
2 min

Swiss Medic: Guidance on Packaging for Human Medicinal Products

Swissmedic has issued detailed guidance on (01 August, 2024) on the "Packaging for Human Medicinal Products" to ensure their safety,...

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FDA (ICH) Guidance: M12 Drug Interaction Studies & Questions and Answers

Sharan Murugan

Aug 3
2 min

FDA (ICH) Guidance: M12 Drug Interaction Studies & Questions and Answers

Yesterday (02 August, 2024), the Food and Drug Administration (FDA) announced that the final guidance on M12 drug interactions was...

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USFDA Guidance: User Fee Programs: GDUFA, BSUFA, OMOR, and MDUFA

Sharan Murugan

Jul 31
3 min

USFDA Guidance: User Fee Programs: GDUFA, BSUFA, OMOR, and MDUFA

On July 31, 2024 the U.S. Food and Drug Administration (FDA) recently published in the Federal Register notice (FRN) the User Fee Rates...

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Australia TGA MD Guidance: Essential Principle 13B & Regulation of Software based Medical Devices

Sharan Murugan

Jul 29
2 min

Australia TGA MD Guidance: Essential Principle 13B & Regulation of Software based Medical Devices

Australia's Therapeutic Goods Administration (TGA) provided comprehensive guidance on "Essential Principle 13B", which pertains to the...

18 views0 comments