Regulatory Blog

On December 10, 2021, the FDA published the draft guidance for industry entitled “Cover Letter Attachments for Controlled Correspondences...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

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Yesterday, the USFDA issued draft guidance for the industry titled Real-World Data: Assessing Registries to Support Regulatory...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

The current challenges with the eCTD system that the agency currently uses, explaining how it does “not follow the development flow of...

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...

The Parliament of Finland has adopted a new Act on Clinical Trials on 8 October 2021. The Parliament also approved amendments to the...

Saudi Arabia’s (SFDA) updated Guide on Regulatory Framework for Drug Registration, Variation or Renewal The Drug Sector in Saudi Food &...

This guideline is intended to provide information and guidance to applicants/HCRs on the prescribed requirements and process to be...

This guidance summarises UK-MHRA’s approach to pharmacovigilance. The Guidance on pharmacovigilance procedures was Updated on 14 October...

The International Council for Harmonization (ICH) Endorsed on 6 October 2021 its (Addendum to M7(R2)) M7(R2) draft guideline setting new...