Regulatory Blog

Recently the UK's Medicines and Healthcare products Regulatory Agency (MHRA) updated their "150-day assessment for national applications...

Recently in a new program announced by the Food and Drug Administration (USFDA), a limited number of applicants will be able to...

The Drug Regulatory Authority of Pakistan (DRAP) released a finalized guideline "Preparation of Summary of Product Characteristics...

Earlier today (28-October-2022) the USFDA released final guidance on "Developing and Responding to Deficiencies in Accordance with the...

Earlier today (27-October-2022) the Saudi Food & Drug Authority (SFDA) released updated guidance on "Good Regulatory Practice". A Good...

Denmark's Danish Medicines Agency recently announced on 11th October 2022, going forward the current Danish QRD template is to be used...

Earlier on 21 October 2022, the USFDA released two finalized guidances "Multiple Endpoints in Clinical Trials" and "Human Gene Therapy...

Earlier on 21 October 2022, the USFDA released draft guidance "Select Updates for the Breakthrough Devices Program Guidance: Reducing...

The USFDA recently revised two compliance programs, which will go into effect from, October 17, 2022: Preapproval Inspections Drug...

Yesterday (October 21, 2022) USFDA Released multiple New draft guidelines providing guidance on topical generic drug product...

The Medicines and Healthcare products Regulatory Agency (MHRA) recently updated a few guidances related to registration &...

USFDA's Oncology Center of Excellence released multiple guidances related to Oncology earlier today (17-Oct-2022). Guidance on:...

Center for Drug Evaluation and Research (CDER) finalized and released updated guidance on "ANDA Submissions – Prior Approval Supplements...

This guidance was finalized and released by the Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and...

European Medicines Agency (EMA) recently updated (14-October-2022) its guidance on "Scientific advice and protocol assistance" and also...

The Medicines and Healthcare Products Regulatory Agency (MHRA) has begun reforming medical device regulation to ensure software,...

Earlier today Today (13 October 2022) Medicines and Healthcare products Regulatory Agency (MHRA) updated its Guidance on Medicines:...

Recently EMA released an updated guidance document for the purpose of simplifying the completion of the application form process for...

The Medicines and Healthcare products Regulatory Agency (MHRA) recently updated a couple of guidances related to Exporting active...

Recently Japan's the Ministry of Health, Welfare and Labour (MHLW) - Pharmaceuticals and Medical Devices Agency issued a Notification...