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Yesterday (19 September 2023) the U.S. Food and Drug Administration (FDA) released two draft guidance "Regulatory Considerations for...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

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: 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

UK MHRA: Guidance on International Recognition Procedure

Recently the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released a guidance on "International Recognition Procedure"...

Sharan Murugan

Sep 9, 20231 min read

USFDA Guidance: Informed Consent Guidance for IRBs, Clinical Investigators, & Sponsors

The U.S. Food and Drug Administration (FDA) released its final guidance this Tuesday (15 August 2023), "Informed Consent: Guidelines for...

Sharan Murugan

Aug 17, 20231 min read

USFDA Guidance: QTc Information in Prescription Drug & Biological Product Labeling

Recently on 08 August 2023, the United States Food & Drug Administration's Oncology Center of Excellence, Center for Drug Evaluation and...

Sharan Murugan

Aug 10, 20232 min read

USFDA Guidance: Recommended Acceptable Intake Limits for Nitrosamine DS-Related Impurities

Today (04 August 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug...

Sharan Murugan

Aug 4, 20232 min read

USFDA Guidance: Waivers, Exceptions, & Exemptions from Section 582 of FD&C Act

Today (04 August 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug...

Sharan Murugan

Aug 4, 20232 min read

USFDA Guidance: Assessing User Fees -BsUFA III: Biosimilar User Fee Amendments of 2022

Today (31 July 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug...

Sharan Murugan

Aug 1, 20232 min read

Malaysia NPRA: Guidance on Drug Registration

Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (26 July, 2023) released an updated guidance on "Drug Registration"...

Sharan Murugan

Jul 30, 20232 min read

Canada HC Guidance: Nitrosamine Impurities in Medications

Last Friday (28 July, 2023) Health Canada published an updated "Guidance on Nitrosamine Impurities in Medications" that details about...

Sharan Murugan

Jul 30, 20231 min read

UK MHRA: Guidance on Renewing Marketing Authorisations & Implementation of Med Dev. Future Regime

Guidance on Renewing Marketing Authorisations Recently (28, July 2023) the UK's Medicines and Healthcare Products Regulatory Agency...

Sharan Murugan

Jul 30, 20231 min read

UK MHRA: Guidance on Labelling & Packaging of Medicinal Products - Windsor Framework

On 27 July 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Labelling and packaging of...

Sharan Murugan

Jul 30, 20232 min read

USFDA Guidance: ICH M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities

Earlier today (25 June, 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research, and Center for...

Sharan Murugan

Jul 24, 20232 min read

EC Guidance: Transition from Clinical Trials Directive to the Clinical Trials Regulation

The European Commission (EC) has long recognized the importance of streamlining and harmonizing the regulation of clinical trials across...

Sharan Murugan

Jul 24, 20232 min read

Switzerland's SwissMedic: Harmonisation of the SwissGMP/GDP Inspection System

Yesterday (20 July 2023) Switzerland's Swissmedic released an updated guidance on "Harmonisation of the SwissGMP/GDP Inspection System"...

Sharan Murugan

Jul 21, 20232 min read