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Swissmedic Guidance on Product Information for Human Medicinal Products
Swissmedic, the Swiss Agency for Therapeutic Products, has introduced its updated guidance  on " Product Information for Human Medicinal...
Sharan Murugan
Nov 16, 20242 min read
24 views
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US FDA Draft Guidance: Drug Interaction Information in Human Prescription Drug and Biological Product Labeling
The US FDAÂ released a draft guidance on 21st October 2024 outlining the recommendations for " Drug Interaction Information in Human...
Sharan Murugan
Oct 22, 20242 min read
14 views
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Swissmedic Guidance: Product Information for Human Medicinal Products
The Swissmedic released an updated guidance "Product information for Human Medicinal Products" which provides comprehensive instructions...
Sharan Murugan
Jul 13, 20242 min read
16 views
0 comments
Ireland's HPRA: Guide to Labels and Leaflets of Human Medicines
Last Friday (09 February 2024) the Health Products Regulatory Authority (HPRA) of Ireland updated its guidance on "Labels and Leaflets of...
Sharan Murugan
Jun 23, 20242 min read
68 views
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USFDA Guidance: Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling
Today (29 April 2024), FDA released a new draft guidance for the industry titled "Content and Format of Composition Statement and...
Sharan Murugan
Apr 27, 20242 min read
29 views
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USFDA Guidance: Annual Reportable Labeling Changes for NDA and ANDA for Nonprescription Drug Products
Today (13 March, 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released the draft guidance...
Sharan Murugan
Mar 13, 20242 min read
56 views
0 comments
UK MHRA: Guidance on Packaging, Labelling and Patient Information Leaflets
Earlier today (08 March 2024) Medicines and Healthcare Products Regulatory Agency (MHRA) updated its "Guidance on Medicines: Packaging,...
Sharan Murugan
Mar 7, 20242 min read
54 views
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TGA MD Guidance: Medical Device Labelling Obligations
On Monday (19 February, 2024) Australia's Therapeutic Goods Administration (TGA) released updated guidance on the "Medical Device...
Sharan Murugan
Feb 22, 20241 min read
108 views
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USFDA Guidance: Navigating ANDA Submissions Latest Guidance on ANDA Amendments, Requests, and Labeling Revisions
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released two updated final guidances on 24 January...
Sharan Murugan
Jan 28, 20242 min read
31 views
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UK MHRA: Guidance on Submitting Changes to Labelling and Patient Information Leaflets
On 22nd December 2023, the Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance on Medicines "Submitting...
Sharan Murugan
Dec 27, 20232 min read
48 views
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USFDA Guidance: Dose Banding - Labeling for Dosing Based on Weight or Body Surface Area
Earlier today (2 October 2023), The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Center for Biologics...
Sharan Murugan
Oct 2, 20232 min read
24 views
0 comments
USFDA Guidance: Labeling for Biosimilar & Interchangeable Biosimilar Products
Earlier this Monday (18 September 2023), The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center...
Sharan Murugan
Sep 20, 20232 min read
19 views
0 comments
USFDA Guidance: QTc Information in Prescription Drug & Biological Product Labeling
Recently on 08 August 2023, the United States Food & Drug Administration's Oncology Center of Excellence, Center for Drug Evaluation and...
Sharan Murugan
Aug 10, 20232 min read
26 views
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UK MHRA: Guidance on Labelling & Packaging of Medicinal Products - Windsor Framework
On 27 July 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Labelling and packaging of...
Sharan Murugan
Jul 30, 20232 min read
194 views
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USFDA Statement: New Patient Medication Information - Medication Guide for Patients
Yesterday (31 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research (CDER) proposed a new...
Sharan Murugan
Jun 1, 20231 min read
30 views
0 comments
Malaysia NPRA: Guideline on Electronic Labelling (E-LABELLING) for Pharmaceutical Products
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (11 April, 2023) released an updated guideline on " Electronic...
Sharan Murugan
Apr 18, 20231 min read
71 views
0 comments
USFDA Guidance: Content & Format - Dosage and Administration Section of Labeling
Recently on 12-January-2023, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled...
Sharan Murugan
Jan 17, 20231 min read
46 views
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Malaysia’s MDA: Med Dev Guidance on Requirement for Labeling & Change Notification of Registered MD
Recently on 21st November, 2022 the Malaysian Medical Device Authority (MDA) updated its guidelines regarding the "Requirement for...
Sharan Murugan
Nov 27, 20221 min read
17 views
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Japan PMDA: Guidelines for Labeling of Codes on Containers to Identify Prescription Drugs & Med. Dev
Recently Japan's the Ministry of Health, Welfare and Labour (MHLW) - Pharmaceuticals and Medical Devices Agency issued a Notification...
Sharan Murugan
Oct 9, 20221 min read
23 views
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EMA Guidance: Checking process of Mock-ups & Specimens of Outer/Immediate Labelling & PI -CP
Earlier on 27th Spetmber, 2022 EMA revised and released their updated Regulatory and procedural guideline on "Checking process of...
Sharan Murugan
Sep 30, 20222 min read
445 views
0 comments