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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
0 comments
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
160 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
322 views
0 comments
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
118 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
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
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
36 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
0 comments
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
63 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
178 views
0 comments
USFDA Guidance: Content of Premarket Submissions for Device Software Functions
Last Wednesday (14 June 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health, Center for...
Sharan Murugan
Jun 17, 20231 min read
23 views
0 comments
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
68 views
0 comments
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
0 comments
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
0 comments
Philippines FDA: Guidelines on the Application for License to Operate
Yesterday (6 June 2023) the Philippines Food and Drug Administration (FDA) released an updated draft guideline "Guidelines on the...
Sharan Murugan
Jun 6, 20231 min read
224 views
0 comments