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USFDA Guidance: Statistical Approaches to Establishing Bioequivalence
Today (o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft guidance...
Sharan Murugan
Dec 2, 20221 min read
USFDA Guidance: ANDAs Pre-Submission Facility Correspondence Related to Prioritized Generic Drug
Earlier today (o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft...
Sharan Murugan
Dec 2, 20221 min read
South Africe SAPHRA Guideline: For the API Master File (APIMF) Procedure
Recently last week the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline for the API Master File...
Sharan Murugan
Nov 27, 20221 min read
Philippines FDA: Guidance Reliance for Regulatory Decisions & Regulatory Response on National PHE
Recently on 25th November, 2022 Philippines Food and Drug Administration (FDA) released two draft guidelines for comments i.e;...
Sharan Murugan
Nov 27, 20222 min read
Swissmedic: Guideline Amendments Clinical Trials & Clinical Trial Application Dossier
Earlier today (23-November-2022) Swissmedic released two updated guidelines "Guideline Amendments Clinical Trials" and "Clinical Trial...
Sharan Murugan
Nov 23, 20221 min read
SFDA Guidance: Registration Rules of Pharmaceutical Product Manufacturers & their Products
Saudi Food & Drug Authority on 17th November 2022, released an updated guidance on "The Registration Rules of Pharmaceutical, Herbal and...
Sharan Murugan
Nov 19, 20221 min read
UK MHRA: Guidance on EC Decision Reliance Procedure Extended till 31 Dec, 2023 & Nitrosamine Risk
On 18th November 2022 the UK's Medicines and Healthcare products Regulatory Agency released its updated guidance on the "European...
Sharan Murugan
Nov 19, 20221 min read
SFDA Guidance: Conditional Approval for Medicinal Products for Human Use
The Saudi Food and Drug Authority recently released (13- November-2022) updated guidance on "Conditional Approval for Medicinal Products...
Sharan Murugan
Nov 16, 20221 min read
USFDA POLICY AND PROCEDURES: Quality Assessment for Products in Expedited Programs
Recently (10 November 2022), the U.S. Food and Drug Administration published a new Manual of Policies and Procedures (MAPP), MAPP 5015.13...
Sharan Murugan
Nov 12, 20221 min read
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation
On 11 November 2022, the European medicines agency released updated guidance for sponsors about the "Procedural Advice for Orphan...
Sharan Murugan
Nov 12, 20221 min read
USFDA Guidance: Sameness Evaluations in an ANDA — Active Ingredients
Earlier today (November 8, 2022) USFDAs Center for Drug Evaluation and Research, Office of Generic Drugs released a Draft guideline on...
Sharan Murugan
Nov 8, 20221 min read
EMA Guidance: Anonymisation of PPD & CCI - Preparation of Risk Management Plans (RMP)
Today (04-November-2022) European Medicines Agency, released updated guidance on "Anonymisation of Protected Personal Data and assessment...
Sharan Murugan
Nov 4, 20221 min read
EMA Guidance: Pre & Post-Authorisation Procedural Advice for Users of the Centralised Procedure
Earlier today (04-November-2022) the European Medicines Agency (EMA) released updated guidance on "Pre-Authorisation Procedural Advice...
Sharan Murugan
Nov 4, 20221 min read
USFDA Guidance: Expanded Access to IND Q&A and Assessing User Fees under OMUFA
Earlier Today (1-November-2022), the U.S. Food and Drug Administration issued a revised draft guidance for the industry, “Expanded Access...
Sharan Murugan
Nov 1, 20221 min read
USFDA Guidance: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Earlier today (1-November-2022) the USFDA finalized and released "Regulation of Human Cells, Tissues, and Cellular and Tissue-Based...
Sharan Murugan
Nov 1, 20221 min read
UK MHRA: 150-Day Assessment for National Applications
Recently the UK's Medicines and Healthcare products Regulatory Agency (MHRA) updated their "150-day assessment for national applications...
Sharan Murugan
Nov 1, 20221 min read
USFDA's Notice: CMC Development & Readiness Pilot Program
Recently in a new program announced by the Food and Drug Administration (USFDA), a limited number of applicants will be able to...
Sharan Murugan
Nov 1, 20221 min read
DRAP Guidelines: Preparation of Summary of Product Characteristics (SmPC)
The Drug Regulatory Authority of Pakistan (DRAP) released a finalized guideline "Preparation of Summary of Product Characteristics...
Sharan Murugan
Oct 27, 20221 min read
SFDA Guidance: Good Regulatory Practice & National Diagnostic Reference Levels
Earlier today (27-October-2022) the Saudi Food & Drug Authority (SFDA) released updated guidance on "Good Regulatory Practice". A Good...
Sharan Murugan
Oct 27, 20221 min read
Denmark DMA: Current Danish QRD Template for Granting MA
Denmark's Danish Medicines Agency recently announced on 11th October 2022, going forward the current Danish QRD template is to be used...
Sharan Murugan
Oct 23, 20221 min read