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Sharan Murugan
Sep 1, 20221 min read
Singapore HSA: Safety Alert for Finasteride and Potential Risk of Suicidal iIdeation
The Singapore Health Sciences Authority (HSA) published a Safety Alert for Finasteride on 30-August-2022. Suicidal ideation is a known...
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Sharan Murugan
Sep 1, 20221 min read
EMA Guidance: For Applicants/MAHs involved in GMP and GCP Inspections
On August 31, 2022 the EMA updated its guidance "Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by...
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Sharan Murugan
Aug 30, 20221 min read
Health Canada Recommendations: ICH Q3D(R2) Guideline for Elemental Impurities
Yesterday (29-August-2022) Health Canada notified that Recommendations on the Implementation of the Revised ICH Q3D(R2) Harmonized...
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Sharan Murugan
Aug 30, 20221 min read
SFDA Guide to Good Manufacturing Practice for Medicinal Products
On August 28, the Saudi Food and Drug Authority updated its "Guide to Good Manufacturing Practice for Medicinal Products". The new...
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Sharan Murugan
Aug 27, 20222 min read
ICH Guidances: Q2(R2) Validation of Analytical Procedures, Q14, M12, E11A, E14 & S7B Updation
In an announcement yesterday, USFDA released the below draft guidances for industry, developed with the assistance of ICH, the...
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Sharan Murugan
Aug 25, 20221 min read
SFDA: Guidelines for Stability Testing of API and Finished Pharmaceutical Products
On August 23, the Saudi Food and Drug Authority updated its "Guidelines for Stability Testing of Active Pharmaceutical Ingredients and...
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Sharan Murugan
Aug 25, 20221 min read
EMA: Updated EudraVigilance Registration Manual
EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been...
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Sharan Murugan
Aug 24, 20221 min read
Gilead: First Regulatory Approval of HIV Sunlenca® (Lenacapavir) the Only Twice-Yearly HIV Treatment
On 22-August-2022, Sunlenca (lenacapavir) is an injectable HIV medication developed by Gilead Sciences that has been approved to market...
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Sharan Murugan
Aug 22, 20221 min read
USFDA Guidance: Charging for Investigational Drugs Under an IND: Questions and Answers
This draft guidance is released today for Public comments and when finalized, this guidance will replace Charging for Investigational...
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Sharan Murugan
Aug 21, 20221 min read
Australia TGA: Regulatory Guidelines for Medical Devices (ARGMD)
The Australian Regulatory Guidelines for Medical Devices (ARGMD) released updated guidance on 19-August-2022, which provides information...
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Sharan Murugan
Aug 17, 20222 min read
USFDA's Guidance on Hearing Aid Devices, Replacement Reagent & Contact Lens Care Products
Today USFDA's Center for Devices and Radiological Health updated multiple guidances such as "Regulatory Requirements for Hearing Aid...
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Sharan Murugan
Aug 17, 20221 min read
UK MHRA's: Apply for a Parallel Import Licence (Guidance Update)
Today (17 August 2022) MHRA updated its Guidance on "Medicines: apply for a parallel import licence" The guidance in general details...
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Sharan Murugan
Aug 12, 20221 min read
Europe's EDQM: Nitrosamines – Deadline Extension for all CEP Holders - Now 1 October 2023
Nitrosamines are chemical compounds classified as probable human carcinogens on the basis of animal studies. EU regulators first became...
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Sharan Murugan
Aug 9, 20221 min read
UK MHRA Guidance on: Manage your authorisation & Report Safety Issues
Today (9 August 2022) MHRA updated their Guidance on Clinical trials for medicines to manage authorisation, and report safety issues. The...
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Sharan Murugan
Aug 9, 20221 min read
Colombia's Invima and USP: Memorandum to Strenghthen the Quality of Medicine
Recently the National Institute for Food and Drug Surveillance - Invima and the United States Pharmacopeia - USP, celebrated the signing...
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Sharan Murugan
Aug 7, 20221 min read
USFDA's New WebPage: For Complex Generics
Friday the USFDA agency published a new web page to share the most recent FDA actions and activities related to complex generics, which...
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Sharan Murugan
Aug 4, 20221 min read
Health Canada: Guidance Document Management of Drug Submissions and Applications & Post-DIN Changes
Health Canada on August 2, 2022, revised the Guidance Document entitled: The Management of Drug Submissions and Applications (MDSA). This...
220 views0 comments
Sharan Murugan
Aug 4, 20221 min read
UK MHRA Guidance: Medicines: How to Reclassify your Product
Today (August 4, 2022) UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance for the industry, “Guidance:...
177 views0 comments
Sharan Murugan
Aug 2, 20221 min read
Swiss Medic Guidance: Authorisation Procedures for Covid-19 Medicinal products
Yesterday (01.08.2022) the Swiss Medic updated their "Guidance document on Authorisation procedures for Covid-19 medicinal products...
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Sharan Murugan
Aug 2, 20221 min read
USFDA Guidance: Electronic Submission of Expedited Safety Reports From IND- Exempt BA/BE Studies
Today (August 2, 2022) FDA published draft guidance for the industry, “Electronic Submission of Expedited Safety Reports from IND-Exempt...
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