Regulatory Blog

The U.S. Food and Drug Administration, yesterday announced the release of a draft guidance, Essential Drug Delivery Outputs for Devices...

The Saudi Food & Drug Authority (SFDA) has released updated guidance on "Regulatory Framework for Drugs Approval". This comprehensive...

The European Commission Medical Device Coordination Group (MDCG) has issued a new guidance "Clinical Evaluation of Orphan Medical...

The Therapeutic Goods Administration (TGA) in Australia has issued guidance (21 June, 2024) on the "Regulatory Obligations for Exempt...

Swissmedic, the Swiss Agency for Therapeutic Products, has issued a detailed guidance document "Requesting Certificates of Pharmaceutical...

The European Commission has recently published two new guidance documents on Health Technology Assessment (HTA), dated June 13, 2024....

Last Friday (09 February 2024) the Health Products Regulatory Authority (HPRA) of Ireland updated its guidance on "Labels and Leaflets of...

The USFDA's updated guidance (21 June, 2024) on "Considerations in Demonstrating Interchangeability With a Reference Product" provides...

The US FDA has released final guidance for industry applicants "Facility Readiness: Goal Date Decisions Under GDUFA" which helps assign...

Swissmedic, the Swiss Agency for Therapeutic Products, has published comprehensive guidance "Renewal and Discontinuation of Authorization...

The US Food and Drug Administration (FDA) released the final guidance yesterday (14 June 2024) titled "Clinical Pharmacology...

The European Medicines Agency (EMA) has proposed amendments to the European Commission's "Guidelines on Variations Categories and...

Last Thursday (13 June 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Machine...

Swissmedic, the Swiss Agency for Therapeutic Products, is responsible for ensuring that only high-quality, safe, and effective medical...

The US Food and Drug Administration (USFDA) is announcing the availability of a draft guidance for the industry entitled “Processes and...

The Central Drugs Standard Control Organisation (CDSCO) has issued comprehensive guidance on (29 May, 2024) "Guidance for Industry on...

The European Medicines Agency (EMA) yesterday(04 June 2024) updated and released the guidance document "Procedural Advice on Paediatric...

On 03-June-2024 the European Medicines Agency released an updated "IRIS Guide for Applicants" that guides How to create, submit and...