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Sharan Murugan
Sep 8, 20222 min read
USFDA Guidance: Content & Format of Labeling for Non-Prescription Drugs, Quantitative Labeling
Earlier today on 8-September-2022, USFDA's Center for Drug Evaluation and Research, Office of New Drugs published two draft Labeling...
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Sharan Murugan
Jul 24, 20221 min read
USFDA: Revising the National Drug Code Format and Drug Label Barcode Requirements
On July 22, 2022, FDA announced the availability of a proposed rule, Revising the National Drug Code Format and Drug Label Barcode...
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Sharan Murugan
Jul 24, 20221 min read
SwissMedic updated Guidance: Packaging for Human Medicinal Products
Recently on 14-July 2022, SwissMedic updated their "Packaging for human Medicinal Products" guidance. This guidance document explains how...
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Sharan Murugan
May 22, 20221 min read
USFDA's Guidance on Safety Considerations for Container Labels and Carton Labeling
FDA has issued the final guidance titled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication...
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Sharan Murugan
May 2, 20221 min read
Guidelines on Labeling Requirements of Drug Products under Maximum Retail Price - Philippines FDA
The Philippines' Food and Drug Administration (FDA) is seeking feedback on draft guideline aimed at streamlining the process of changing...
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Sharan Murugan
Apr 24, 20221 min read
Pakistan (DRAP) Draft Guidelines on FP Labeling & Packaging and BA-BE Guidelines
Finished Product Labeling and Packaging Guidelines To provide guidance on how to make sure the information on labels and package leaflets...
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Sharan Murugan
Apr 24, 20221 min read
Malaysia’s MDA- Draft Medical Device Labeling Guidance
The Medical Device Authority (MDA) of Malaysia is seeking feedback on draft regulations for medical device labeling. The MDA's fifth...
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Sharan Murugan
Apr 13, 20222 min read
FDA Guidance:Providing Submissions in Electronic & Non-Elec Format—Promotional Labeling &Advertising
On 11-March-2022, FDA released the final guidance "Providing Regulatory Submissions in Electronic and Non-Electronic 1 Format —...
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Sharan Murugan
Feb 20, 20221 min read
Ireland’s HPRA - Guidance update on Submitting Mock-ups for Labels and Leaflets
A number of important revisions and clarifications were made in the HPRA's Guide to Labels and Leaflets of Human Medicines on 9 February...
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Sharan Murugan
Feb 6, 20221 min read
Guidance on Revising ANDA Labeling Following Revision of the RLD Labeling
This guidance is intended to assist applicants and holders of an abbreviated new drug application (ANDA) in updating their labeling...
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Sharan Murugan
Aug 23, 20211 min read
GCC Guidance on Labeling Information, SPC and PIL - Gulf Cooperation Council & SFDA
The Gulf Health Council released a new updated version of the guidance on 12th August 2021 on “Guidance for Presenting the Labeling...
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Sharan Murugan
Jul 28, 20211 min read
FDA’s revised MAPP Procedures for Generic Drug Labeling Change
FDA on July 26, 2021, published a revision to the Manual of Policies and Procedures (MAPP 5230.3), “Generic Drug Labeling Revisions” The...
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Sharan Murugan
Jun 26, 20211 min read
Guide to Labels and Leaflets of Human Medicines- IRELAND (HPRA)
Product labels and the package leaflet play an essential part in the safe and effective use of the medicine by both the patients and...
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