Regulatory Blog

Priority Review indicates that the review process of the application will be expedited by the concerned departments. However, the...

This new pathway supports innovative approaches to the safe, timely, and efficient development of medicines to improve patient access....

Senior US Senator Chuck Grassley has urged to "reinstate unannounced" inspections of prescription drug manufacturing facilities in...

This guidance was developed within the Expert Working Group (Quality) of the International Council for Harmonisation of Technical...

This guidance provides recommendations to holders of biologics license applications (BLAs) for specified biological products regarding...

On December 10, 2021, the FDA published the draft guidance for industry entitled “Cover Letter Attachments for Controlled Correspondences...

Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of...

The COA Compendium is part of the FDA’s efforts to foster patient-focused drug development. The COA Compendium is intended to facilitate...

Parallel importation “The importation from an EU Member State, or an EEA country, of a medicinal product which is equivalent to one...

Saudi Food & Drug Authority released updated guidance on Regulations and Requirements for Conducting Clinical Trials in regards to “Early...

On December 2,2021 the U.S. (FDA) published the Fiscal Year (FY) 2022 Generic Drug User Fee Amendments (GDUFA) Science and Research...

UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on requesting a pharmacovigilance system master file...

Yesterday, the USFDA issued draft guidance for the industry titled Real-World Data: Assessing Registries to Support Regulatory...

This guidance has been developed to assist those involved in clinical trials disrupted as a result of COVID-19. It is relevant to those...

Standards and reference substances play a vital role in evaluating the quality of active pharmaceutical ingredients and finished...

This guidance document addresses a number of questions that marketing authorisation holders (MAHs) may have on post-authorisation...

Drug Regulatory Authority of Pakistan (DRAP) has released draft guidelines that describe the requirements for commercial imports and...

Drug-Medical Device Combination Product (DMDCP): Primary mode of action is based on pharmacological, immunological or metabolic action...

This guidance provides recommendations to sponsors for complying with section 745A(a) of the 30 FD&C Act (21 U.S.C. 379k-1(a)) when...

This guideline addresses the methodological, regulatory and operational aspects involved in using registry-based studies to support...