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ICH Guidance: M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines
FDA (FDA or Agency) has announced the availability of a draft guidance for the industry called “M14 General Principles on Planning,...
Sharan Murugan
Jul 3, 20242 min read
USFDA: Guidance on Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products
The U.S. Food and Drug Administration, yesterday announced the release of a draft guidance, Essential Drug Delivery Outputs for Devices...
Sharan Murugan
Jun 29, 20242 min read
Saudi's SFDA: Guidance on Regulatory Framework for Drugs Approval
The Saudi Food & Drug Authority (SFDA) has released updated guidance on "Regulatory Framework for Drugs Approval". This comprehensive...
Sharan Murugan
Jun 28, 20242 min read
Swissmedic Guidance: Requesting Product Certificates (CPP)
Swissmedic, the Swiss Agency for Therapeutic Products, has issued a detailed guidance document "Requesting Certificates of Pharmaceutical...
Sharan Murugan
Jun 23, 20242 min read
European Commission: Health Technology Assessment -Guidance on Outcomes for Joint Clinical Assessments and Reporting Requirements
The European Commission has recently published two new guidance documents on Health Technology Assessment (HTA), dated June 13, 2024....
Sharan Murugan
Jun 23, 20242 min read
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
USFDA Guidance: Interchangeability: Considerations in Demonstrating Interchangeability With a Reference Product
The USFDA's updated guidance (21 June, 2024) on "Considerations in Demonstrating Interchangeability With a Reference Product" provides...
Sharan Murugan
Jun 22, 20242 min read
USFDA Guidance: Facility Readiness: Goal Date Decisions Under GDUFA
The US FDA has released final guidance for industry applicants "Facility Readiness: Goal Date Decisions Under GDUFA" which helps assign...
Sharan Murugan
Jun 20, 20242 min read
Swissmedic Guidance: Renewal and Discontinuation of Authorization or Change of Status (Main Authorization/Export License)
Swissmedic, the Swiss Agency for Therapeutic Products, has published comprehensive guidance "Renewal and Discontinuation of Authorization...
Sharan Murugan
Jun 15, 20242 min read
USFDA Guidance: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics
The US Food and Drug Administration (FDA) released the final guidance yesterday (14 June 2024) titled "Clinical Pharmacology...
Sharan Murugan
Jun 15, 20242 min read
EMA Guidance: Proposed Amendments - Variations Categories and Procedures
The European Medicines Agency (EMA) has proposed amendments to the European Commission's "Guidelines on Variations Categories and...
Sharan Murugan
Jun 15, 20242 min read
Swiss Medic: Guidances on Varaiations, Temporary Authorisation, Meetings for Applicants and Time Limits for Authorisation
Swissmedic, the Swiss Agency for Therapeutic Products, is responsible for ensuring that only high-quality, safe, and effective medical...
Sharan Murugan
Jun 9, 20242 min read
USFDA Guidance: BIMO Inspections Processes, Practices & Standardized Format for Electronic Submission
The US Food and Drug Administration (USFDA) is announcing the availability of a draft guidance for the industry entitled “Processes and...
Sharan Murugan
Jun 9, 20242 min read
India CDSCO: Guidance for Industry on Pharmacovigilance Requirements for Human Vaccines
The Central Drugs Standard Control Organisation (CDSCO) has issued comprehensive guidance on (29 May, 2024) "Guidance for Industry on...
Sharan Murugan
Jun 5, 20242 min read
EMA Guidance: Procedural Advice on Paediatric Applications
The European Medicines Agency (EMA) yesterday(04 June 2024) updated and released the guidance document "Procedural Advice on Paediatric...
Sharan Murugan
Jun 5, 20242 min read
EMA Guidance: IRIS Guide for Applicants
On 03-June-2024 the European Medicines Agency released an updated "IRIS Guide for Applicants" that guides How to create, submit and...
Sharan Murugan
Jun 5, 20242 min read
ICH M14 Guideline: General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines
Recently the International Council for Harmonisation (ICH) announced on 24 May, 2024 the availability of draft guidance for the industry...
Sharan Murugan
May 31, 20242 min read
USFDA Guidance: Platform Technology Designation Program for Drug Development
Today (29 May 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics...
Sharan Murugan
May 28, 20242 min read
Malaysia NPRA: Electronic Labelling (E-Labelling) Guidance For Pharmaceutical Products
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (21 May, 2024) released an updated guideline on " Electronic...
Sharan Murugan
May 25, 20242 min read
Philippines FDA: Authorization for Registration Applications of Pharmaceutical Products and Active Pharmaceutical Ingredients for Human Use
The Philippines Food and Drug Administration (FDA) has released a draft (for comments) "Rules and regulations for the authorization and...
Sharan Murugan
May 18, 20241 min read