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USFDA MD Guidance: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices

Recently (10th October 2023) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released multiple...

Sharan Murugan

Oct 14, 20231 min read

EMA Guidance: Post-Authorisation Procedural Advice for Users of the Centralised Procedure

Yesterday (13 October 2023) the European Medicines Agency released an updated guidance on "European Medicines Agency post-authorisation...

Sharan Murugan

Oct 14, 20231 min read

UK MHRA: Clinical Trials for Medicines: Apply for Authorisation in the UK

Recently (12 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Clinical Trials...

Sharan Murugan

Oct 14, 20232 min read

EMA Guidance: Qualification of Novel Methodologies for Drug Development, Guidance to Applicants

Recently the European Medicines Agency released an updated guidance on "Qualification of Novel Methodologies for Drug Development:...

Sharan Murugan

Oct 10, 20232 min read

USFDA Guidance: Developing Drugs for Treatment for Stimulant Use Disorders

A draft guidance "Stimulant Use Disorders: Developing Drugs for Treatment" was published yesterday (05 October, 2023) by the US Food and...

Sharan Murugan

Oct 6, 20231 min read

USFDA Guidance: MAPP: Filing Review of Abbreviated New Drug Applications

The FDA revised section 5200.14 of the Manual of Policies and Procedures (MAPP), "Filing Reviews of Abbreviated New Drug Applications...

Sharan Murugan

Oct 4, 20232 min read

USFDA Guidance: Dose Banding - Labeling for Dosing Based on Weight or Body Surface Area

Earlier today (2 October 2023), The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Center for Biologics...

Sharan Murugan

Oct 2, 20232 min read

USFDA MD Guidance: AST System Devices, Technical Considerations & Electronic Submission Template

Recently (29th September 2023) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released multiple...

Sharan Murugan

Oct 2, 20232 min read

USFDA MD Guidance: Cybersecurity-Quality System Considerations & Content of Premarket Submissions

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released a final guidance "Cybersecurity in...

Sharan Murugan

Oct 2, 20231 min read

EC Q&A Guidance: Questions & Answers: Clinical Trials Regulation

Recently this Friday (29-Sepetember, 2023), the European Commission's Clinical Trials Coordination and Advisory Group released an updated...

Sharan Murugan

Oct 2, 20232 min read

EMA Guidance: Pre-Authorisation Procedural Advice for Users of the Centralised Procedure

Last Friday (29 September 2023) the European Medicines Agency released an updated guidance on "European Medicines Agency...

Sharan Murugan

Oct 2, 20231 min read

MHRA Guidance: The Northern Ireland MHRA Authorised Route (NIMAR)

On 29 September 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The Northern Ireland...

Sharan Murugan

Oct 1, 20231 min read

MHRA MD Guidance: Innovative Devices Access Pathway (IDAP) & How to Notify Clinical Investigation

Recently the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The Innovative Devices Access...

Sharan Murugan

Sep 25, 20232 min read

USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants -PDUFA Products

The FDA Center for Drug Evaluation and Research, along with the FDA Center for Biologics Evaluation and Research, issued a revised draft...

Sharan Murugan

Sep 21, 20232 min read

USFDA Guidance: Conduct of Clinical Trials of Medical Products During Major Disruptions

Today (21 September 2023) CDER, along with the FDA Center for Biologics Evaluation and Research, Center for Devices and Radiological...

Sharan Murugan

Sep 21, 20231 min read

USFDA Guidance: Regulatory Considerations for Prescription Drug Use-Related Software

Yesterday (19 September 2023) the U.S. Food and Drug Administration (FDA) released two draft guidance "Regulatory Considerations for...

Sharan Murugan

Sep 20, 20232 min read

TGA Guidance: Submitting data in the eCTD format

Recently (7th Spetember, 2023) Australia's Therapeutic Goods Administration (TGA) released revised and updated guidance "Submitting data...

Sharan Murugan

Sep 11, 20231 min read

USFDA Guidance: IRB Review of Individual Patient Expanded Access Submissions & Peptide Drug Products

Earlier today (11 September 2023), The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Center for...

Sharan Murugan

Sep 11, 20232 min read

USFDA Guidance: Premarket Notification [510(k)] Submissions

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

Sharan Murugan

Sep 10, 20232 min read

USFDA Guidance: Post-Warning Letter Meetings & Interoperable Exchange of Information

Recently on 05 September 2023, the United States Food & Drug Administration's Center for Drug Evaluation and , Research, Center for...

Sharan Murugan

Sep 10, 20232 min read