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Swissmedic Guidance: eDok Submission Update
Swissmedic on Thursday released an updated guidance document on the eDok submission which as included new templates with minor other...
Sharan Murugan
Sep 17, 20221 min read
ICH Guidance: Q3D(R2) ELEMENTAL IMPURITIES
Recently the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released the...
Sharan Murugan
Sep 17, 20221 min read
USFDA Guidance: Submitting Documents Using Real-World Data & RW Evidence for Drug & Biologics
Earlier today (08-September-2022) USFDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research...
Sharan Murugan
Sep 8, 20221 min read
USFDA Guidance: Clinical Pharmacology Considerations for Pediatric Studies of Drugs & Biologics
Yesterday 07-September-2022, USFDA's Center for Drug Evaluation and Research published a draft guideline "General Clinical Pharmacology...
Sharan Murugan
Sep 8, 20221 min read
IRIS Updated Guide: How to Create & Submit Scientific Applications & Accelerating Clin. Trials Plan
On 2-September, 2022 the European Medicines Agency released the updated IRIS guidance on "How to create and submit scientific...
Sharan Murugan
Sep 4, 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...
Sharan Murugan
Sep 1, 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...
Sharan Murugan
Aug 30, 20221 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...
Sharan Murugan
Aug 27, 20222 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...
Sharan Murugan
Aug 7, 20221 min read
EMA Guidance: Prevention of Medicine Shortages in the EU
Recently EMA released new guidance for "patients and healthcare professionals’ organisations" with key principles and examples of good...
Sharan Murugan
Jul 26, 20221 min read
EMA: Plan for Digital Hub for the European Medicines Regulatory Network
A technology capability investment plan has been published by the European Medicines Agency (EMA), which outlines how it plans to invest...
Sharan Murugan
Jul 26, 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...
Sharan Murugan
Jul 24, 20221 min read
USFDA's Guidance: Failure to Respond to an ANDA Complete Response Letter Within the Timeframe
On 22-July 2022, USFDA released multiple guidance among them one is "Failure to Respond to an ANDA Complete Response Letter Within the...
Sharan Murugan
Jul 23, 20222 min read
USFDA Guidance on Providing Regulatory Submissions in Alternate Electronic Format
This updated guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a...
Sharan Murugan
Jun 26, 20221 min read
HPRA Guide to Clinical Trials Conducted under the Clinical Trials Regulation (CTR) in Ireland
The Health Products Regulatory Authority published a guideline and is seeking feedback on its approach to an aspect of Clinical Trial...
Sharan Murugan
Jun 3, 20221 min read
TGA guidance on Testimonials & Endorsements in Advertising
As part of its updated guidelines on testimonials and endorsements in advertising, the Therapeutic Goods Administration (TGA) updated its...
Sharan Murugan
Jun 3, 20221 min read
Free eBook- CAPA in the Pharmaceutical and Biotech Industries
According to the U.S. Food and Drug Administration (FDA), the purpose of a "CAPA program is to collect information, analyze information,...
Sharan Murugan
May 26, 20221 min read
SAPHRA - Guideline on Availability of Medicines for Use in a Public Health Emergency (PHE)
The South African Health Products Regulatory Authority published a guideline that provides recommendations to applicants who intend to...
Sharan Murugan
May 26, 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...
Sharan Murugan
May 22, 20221 min read
Guide to Clinical Trials conducted under the CTR in Ireland
Clinical trials contribute significantly to advances in medical treatment. A new EU Clinical Trial Regulation (Regulation No 536/2014,...
Sharan Murugan
May 8, 20221 min read