Regulatory Blog

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

This is a DRAFT GUIDANCE distributed for comment purposes only. This guidance provides recommendations to sponsors for the collection of...

The US Food and Drug Administration (FDA) has issued draft guidance to help Medical Device Manufacturers comply with postmarket...

After the publication of the Guidance for "Remote Interactive Evaluations", FDA has updated its "Manufacturing, Supply Chain, and Drug...

The guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product...

US Food and Drug Administration (FDA) On April-5, 2021 released new questions and answers guidance for generic drug makers briefing...