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EMA Guidance: Compilation of Union Procedures on Inspections & Exchange of Information
Yesterday (14 July 2023) the European Medicines Agency released an updated regulatory and procedural guideline "Compilation of Union...
Sharan Murugan
Jul 15, 20231 min read
363 views
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USFDA Guidance: Considerations for Optimizing & Standardizing Diet in Clinical Trials (IEM)
Yesterday (11 July, 2023) the USFDA's Center for Drug Evaluation and Research (CDER) released updated guidance on "Inborn Errors of...
Sharan Murugan
Jul 12, 20231 min read
36 views
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Malaysia’s NPRA: Guideline on Manufacturer’s, Import, Wholesaler’s Licenses & Nitrosamine Impurity
Today (12 July, 2023) the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia published a guideline on "Application of...
Sharan Murugan
Jul 12, 20231 min read
135 views
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Pakistan's DRAP: Guidelines for Post-Registration Variation of Drugs
Earlier today (04 July, 2023), the Drug Regulatory Authority of Pakistan released an updated draft guidance on "Guidelines for...
Sharan Murugan
Jul 4, 20231 min read
165 views
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EMA Guideline: Notification of Serious Breaches or the Cinical Trial Protocol
Today (04 July 2023) the European Medicines Agency released a scientific guideline "Guideline for the notification of serious breaches of...
Sharan Murugan
Jul 4, 20232 min read
958 views
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EMA Guidance: Parallel EMA/HTA body (HTAb) Scientific Advice for the Interim Period
Earlier today (03 July 2023) the European Medicines Agency released updated guidance on "Guidance on Parallel EMA/HTA body (HTAb)...
Sharan Murugan
Jul 3, 20231 min read
67 views
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Australia's TGA: Reclassification of Surgical Mesh, Spinal Implants & Completing a Notification Form
Recently on 27th June, 2023 Australia's Therapeutic Goods Administration (TGA) released multiple guidances on the "Reclassification of...
Sharan Murugan
Jul 2, 20232 min read
9 views
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Health Canada: Guidance on Master Files Procedures & Administrative Requirements
Health Canada recently (26 June, 2023) published an updated guidance on "Guidance on Procedures and Administrative Requirements for...
Sharan Murugan
Jul 2, 20231 min read
168 views
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UK MHRA MD Guidance: Borderlines with Medical Devices & Other Products in Great Britain
Yesterday(01 July 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidelines on the "Borderlines...
Sharan Murugan
Jul 2, 20231 min read
33 views
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Singapore's HSA: Regulatory Updates for Therapeutic Product Registration
On 30th June 2023, Singapore's Health Sciences Authority (HSA) released updated guidance on "Regulatory Updates for Therapeutic Product...
Sharan Murugan
Jul 1, 20231 min read
94 views
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Philippines FDA: Publishing of Package Insert & PIL of Registered Drug Product in Verification Port
Recently (23 June, 2023) the Philippines Food and Drug Administration (FDA) released an updated draft guideline for comments "Guidelines...
Sharan Murugan
Jun 27, 20231 min read
136 views
0 comments
EMA Guidance: Procedural Advice on Publication on Withdrawals of Applications related to MA
Today (27 June 2023), the European Medicines Agency released updated guidance on "Procedural Advice on Publication of Information on...
Sharan Murugan
Jun 27, 20231 min read
339 views
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UK MHRA Guidance: Clinical Trials for Medicines: Apply for Authorisation in the UK
Yesterday (27 June 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Clinical Trials...
Sharan Murugan
Jun 27, 20231 min read
48 views
0 comments
USFDA Guidance: Risk & Efficacy Information in Direct-to Consumer Prescription Drug Promo Labeling
A final guidance for the industry was issued today (27 June, 2023) by the US Food and Drug Administration titled "Presenting Quantitative...
Sharan Murugan
Jun 27, 20231 min read
11 views
0 comments
Switzerland's SwissMedic: Guidance on Information of PSURs/PBRER submission
On 21 June 2023, Switzerland's Swissmedic released an updated guidance on "Information of PSURs/PBRER Submission" which describes the...
Sharan Murugan
Jun 25, 20231 min read
122 views
0 comments
USFDA Guidance: Psychedelic Drugs-Considerations for Clinical Investigations
Recently last week Friday (23 June 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research released...
Sharan Murugan
Jun 25, 20231 min read
18 views
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USFDA Guidance: Formal Dispute Resolution and Administrative Hearings for OTC Monograph Drugs
Today (22 June 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research released a draft guidance on...
Sharan Murugan
Jun 22, 20231 min read
21 views
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Switzerland's SwissMedic: Guidance on Authorisation Biosimilar
Yesterday (21 June 2023) Switzerland's Swissmedic released an updated guidance on "Authorisation Biosimilar" which specifies the...
Sharan Murugan
Jun 22, 20231 min read
38 views
0 comments
USFDA Guidance: Pilot Program Oncology Drug Products & In Vitro Diagnostic Tests
Earlier today (20 June, 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health, Center for Drug...
Sharan Murugan
Jun 20, 20231 min read
20 views
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South Africa's (SAPHRA): Renewal Of Human Medicines Requirements and Process
Earlier today (09 June, 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated guideline on "Renewal...
Sharan Murugan
Jun 18, 20231 min read
66 views
0 comments