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

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: 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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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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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: 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...

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UK MHRA: Guidance on Good Clinical Practice for Clinical Trials

Sharan Murugan

Jul 23
2 min

UK MHRA: Guidance on Good Clinical Practice for Clinical Trials

On 22nd July 2024 the UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued comprehensive guidance on " Good Clinical...

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USFDA Guidance: Application User Fees for Combination Products

Sharan Murugan

Jul 16
2 min

USFDA Guidance: Application User Fees for Combination Products

The US Food and Drug Administration published the revised final guidance Application User Fees for Combination Products yesterday (16...

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New EU Regulations on AI in Medical Devices: Key Insights and Implications

Sharan Murugan

Jul 15
2 min

New EU Regulations on AI in Medical Devices: Key Insights and Implications

The European Union has published the finalized text of the Artificial Intelligence Act (AIA) which is a significant step forward in...

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TGA Guidance: Insights into Authorized Prescribers, Ventilator Exports, and Excluded Software

Sharan Murugan

Jul 13
2 min

TGA Guidance: Insights into Authorized Prescribers, Ventilator Exports, and Excluded Software

Navigating regulatory requirements is crucial for pharmaceutical and medical device companies to ensure compliance and facilitate smooth...

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USFDA MD Guidance: Dental Curing Lights & Composite Resin - Premarket Notification (510(k)) Submissions & Devices Intended to Treat OUD

Sharan Murugan

Jul 13
2 min

USFDA MD Guidance: Dental Curing Lights & Composite Resin - Premarket Notification (510(k)) Submissions & Devices Intended to Treat OUD

The US Food and Drug Administration (USFDA) Center for Devices and Radiological Health recently released updated guidelines for dental...

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WHO: MeDevIS Platform and EU MDCG Guidance: Classification Rules for IVDs

Sharan Murugan

Jul 10
2 min

WHO: MeDevIS Platform and EU MDCG Guidance: Classification Rules for IVDs

WHO MeDevIS platform: The World Health Organization (WHO) has established the first global open access clearing house for medical device...

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USFDA Guidance: Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers

Sharan Murugan

Jul 9
2 min

USFDA Guidance: Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers

The US Food and Drug Administration (FDA) issued a draft guidance for the industry yesterday titled “Addressing Misinformation About...

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USFDA Guidance: Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products

Sharan Murugan

Jul 8
2 min

USFDA Guidance: Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products

Today (08 July, 2024) the US Food and Drug Administration (FDA) has released guidance "Purpose and Content of Use-Related Risk Analyses...

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TGA Guidance: Regulatory Changes for Software-Based Medical Devices

Sharan Murugan

Jul 6
2 min

TGA Guidance: Regulatory Changes for Software-Based Medical Devices

The Therapeutic Goods Administration (TGA) has released updated guidance (03 July, 2024) "Regulatory Changes for Software-Based Medical...

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MDCG Med Dev Guidance: Standardisation for Medical Devices

Sharan Murugan

Jul 6
2 min

MDCG Med Dev Guidance: Standardisation for Medical Devices

The Medical Device Coordination Group recently updated the guidance"Standardisation for Medical Devices" include points on topics...

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Swissmedic Guidance: Formal Requirements and SwissPAR

Sharan Murugan

Jul 3
2 min

Swissmedic Guidance: Formal Requirements and SwissPAR

The swissmedic recently on 1st July, 2024 updated and shared two guidances "Guidance: Formal Requirements" and "Guidance: SwissPAR"....

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