Regulatory Blog

This draft guidance document is being distributed for comment purposes only. Cybersecurity incidents have rendered medical devices and...

On 7 April 2022, European Medicines Agency released a draft guidance document on how to approach the protection of personal data and...

As part of its recent announcement, the International Council for Harmonization (ICH) released on 4 April 2022, a draft E11A guideline...

Two draft guidelines were issued by the International Council for Harmonization (ICH) on 31 March 2022 (Thursday), intended to support...

US Food and Drug Administration (FDA) issued draft guidance discussing formal meetings between sponsors of over-the-counter (OTC)...

On December 10, 2021, the FDA published the draft guidance for industry entitled “Cover Letter Attachments for Controlled Correspondences...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

Yesterday, the USFDA issued draft guidance for the industry titled Real-World Data: Assessing Registries to Support Regulatory...

This guidance document is intended to provide information regarding the recommended documentation sponsors should include in premarket...

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...

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

On 28-September, 2021 USFDA released the guidance “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To...

On 30th August 2021, the Center for Devices and Radiological Health released 2 new draft guidance related to Premarket, 510(k). i.e.,...

On 25th August 2021, the Oncology Center of Excellence along with the Center for Drug Evaluation and Research released new draft guidance...

On August 20, 2021, FDA Center for Drug Evaluation and Research (CDER) published a revision to the draft guidance for industry...

World Health Organization (WHO) recently issued revised guidance to industry addressing good manufacturing practices (GMPs) for...

ICH on 27 July 2021, confirmed that the ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 2...

This guidance provides recommendations for clinical trials designed to assess the adhesion performance of transdermal and topical...

Medical devices encompass a vast array of products with different technologies, product lifecycles, complexity, intended users, and...