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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Earlier today (04 July, 2023), the Drug Regulatory Authority of Pakistan released an updated draft guidance on "Guidelines for...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
161 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
884 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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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
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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
337 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
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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
118 views
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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
0 comments
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
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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Health Canada Guidance: Preparation of Regulatory Activities in Non-eCTD Format
Health Canada recently (09 June, 2023) published an updated guidance on "Preparation of Regulatory Activities in Non-eCTD Format" that...
Sharan Murugan
Jun 17, 20231 min read
179 views
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EMA Guidance: Paediatric Submissions Via Syncplicity Web Client
Recently on 09 June 2023, the European Medicines Agency released updated guidance on "Paediatric Submissions Via Syncplicity Web Client"....
Sharan Murugan
Jun 17, 20231 min read
69 views
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MHRA Guidance: 150-Day Assessment for National Applications & Parallel Import Licence
Recently (09 May 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on the "150-Day...
Sharan Murugan
Jun 17, 20231 min read
81 views
0 comments
USFDA Guidance: Assessing User Fees Under the GDUFA of 2022
Today (09 June 2023) the USFDA's Center for Drug Evaluation and Research (CDER) released updated final guidance on "Assessing User Fees...
Sharan Murugan
Jun 8, 20231 min read
20 views
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USFDA Guidance: Clinical Drug Interaction Studies With Combined Oral Contraceptives
A final industry guidance, "Clinical Drug Interactions Studies with Combined Oral Contraceptives", was released by the United States Food...
Sharan Murugan
Jun 8, 20231 min read
23 views
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South Africa's (SAPHRA): Guideline on Pharmacovigilance Systems
Earlier today (06 June, 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated Guideline on...
Sharan Murugan
Jun 6, 20231 min read
36 views
0 comments
USFDA Guidance: Cover Letter Attachments for Controlled Correspondences & ANDA Submissions
The United States Food & Drug Administration published the final guidance "Cover Letter Attachments for Controlled Correspondences and...
Sharan Murugan
Jun 5, 20231 min read
122 views
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SwissMedic Guidance: Orphan Drug, New Active Substance & Prior Notification
Swissmedic recently (02 June 2023) released multiple important guidelines that have captivated the audience and generated significant...
Sharan Murugan
Jun 4, 20232 min read
46 views
0 comments