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TGA Guidance: General Dossier Requirements

Recently on 27th October, 2023 Australia's Therapeutic Goods Administration (TGA) released an updated guidance on the "General Dossier...

Sharan Murugan

Oct 31, 20231 min read

USFDA: Remote Interactive Evaluations of Drug Manufacturing & Bioresearch Monitoring Facilities

Earlier today (25 October,2023), the USFDA issued a draft guidance, "Remote Interactive Evaluations of Drug Manufacturing and Bioresearch...

Sharan Murugan

Oct 25, 20231 min read

USFDA Guidance: Benefit-Risk Assessment for New Drug and Biological Products

A final guidance "Benefit-Risk Assessment for New Drug and Biological Products" was published last week (17 October, 2023) by the US Food...

Sharan Murugan

Oct 23, 20232 min read

EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation

Yesterday (20 October 2023) the European Medicines Agency released an updated guidance on "Procedural Advice for Orphan Medicinal Product...

Sharan Murugan

Oct 21, 20232 min read

UK MHRA Guidance: Apply for a Licence to Market a Medicine in the UK

Last Thursday (19 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for a...

Sharan Murugan

Oct 21, 20231 min read

USFDA Guidance: Policy for Testing of Alcohol & Developing Drugs for DFI Treatment

Earlier today (17 October 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for...

Sharan Murugan

Oct 17, 20232 min read

USFDA Guidance: Quality Considerations for Topical Ophthalmic Drug Products & Stimulant Use Disorder

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released two guidances earlier this week ie, "Quality...

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

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 1, 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 1, 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

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

USFDA Guidance: Labeling for Biosimilar & Interchangeable Biosimilar Products

Earlier this Monday (18 September 2023), The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center...

Sharan Murugan

Sep 20, 20232 min read