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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 –...
Sharan Murugan
Aug 27, 20242 min read
300 views
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Swissmedic Guidance: The Electronic Exchange of ICSRs in E2B(R3) Format Through B2B Gateway
Today (26 August, 2024) the Swissmedic released " guidance for the industry on the electronic exchange of ICSRs in E2B(R3) format...
Sharan Murugan
Aug 26, 20242 min read
20 views
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India CDSCO Guidance: Draft Pharmaceutical Good Distribution Practices (GDP)
The Central Drugs Standard Control Organisation (CDSCO) in India has issued a draft guideline on Good Distribution Practices (GDP) for...
Sharan Murugan
Aug 20, 20242 min read
49 views
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USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA
The U.S. Food and Drug Administration (FDA) on August 19, 2024, published the guidance “ Product-Specific Guidance Meetings Between FDA...
Sharan Murugan
Aug 19, 20242 min read
59 views
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UK MHRA Guidance: Apply for the Early Access to Medicines Scheme (EAMS)
The Medicines and Healthcare Products Regulatory Agency (MHRA) published guidance on "Apply for the early access to medicines scheme...
Sharan Murugan
Aug 18, 20242 min read
21 views
0 comments
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...
Sharan Murugan
Aug 15, 20242 min read
34 views
0 comments
USFDA Guidance: Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases
Last Thursday (08 August 2024) the U.S. Food and Drug Administration (FDA) released final guidance aimed at " Optimizing the Dosage of...
Sharan Murugan
Aug 11, 20242 min read
31 views
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Swiss Medic: Guidance on Packaging for Human Medicinal Products
Swissmedic has issued detailed guidance on (01 August, 2024) on the "Packaging for Human Medicinal Products" to ensure their safety,...
Sharan Murugan
Aug 3, 20242 min read
63 views
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FDA (ICH) Guidance: M12 Drug Interaction Studies & Questions and Answers
Yesterday (02 August, 2024), the Food and Drug Administration (FDA) announced that the final guidance on M12 drug interactions was...
Sharan Murugan
Aug 3, 20242 min read
28 views
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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...
Sharan Murugan
Jul 31, 20243 min read
52 views
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USFDA Guidance: Utilizing Real-World Data in Regulatory Decision-Making for Drug and Biological Products
On July 25, 2024, the U.S. Food and Drug Administration (FDA), through its Center for Drug Evaluation and Research (CDER), Center for...
Sharan Murugan
Jul 27, 20242 min read
10 views
0 comments
USFDA Guidance: Providing Over-the-Counter Monograph Submissions in Electronic Format
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released a final guidance titled "Providing...
Sharan Murugan
Jul 27, 20242 min read
10 views
0 comments
USFDA Guidance: Container Closure System and Component Changes: Glass Vials and Stoppers
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research...
Sharan Murugan
Jul 27, 20242 min read
134 views
0 comments
Swissmedic Guidance: Electronic exchange of ICSRs through PV Gateway
Yesterday (23 July, 2024) Swissmedic, the Swiss Agency for Therapeutic Products, has released updated guidance " Electronic exchange of...
Sharan Murugan
Jul 23, 20242 min read
18 views
0 comments
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...
Sharan Murugan
Jul 23, 20242 min read
12 views
0 comments
USFDA Q&A Guidance: Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products
Today (23 July,2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, and Center for Biologics...
Sharan Murugan
Jul 22, 20242 min read
33 views
0 comments
SAPHRA Guidance: Guideline On Co-Applicancy
The South African Health Products Regulatory Authority (SAHPRA) has released a comprehensive "Guideline on Co-applicancy". This guidance...
Sharan Murugan
Jul 20, 20241 min read
15 views
0 comments
USFDA Guidance: Pediatric IBD Drug Development, Clin.Pharmacology Considerations and BP-Pulse Donor Eligibility Requirements
The US Food and Drug Administration (USFDA) Center for Drug Evaluation and Research recently released updated guidelines "Pediatric...
Sharan Murugan
Jul 20, 20242 min read
7 views
0 comments
EMA Guidance: EudraVigilance Registration Manual
Yesterday the European Medicines Agency (EMA) provided an updated comprehensive guidance on EudraVigilance registration through its...
Sharan Murugan
Jul 20, 20242 min read
49 views
0 comments
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...
Sharan Murugan
Jul 16, 20242 min read
17 views
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