Regulatory Blog

This draft guidance is released today for Public comments and when finalized, this guidance will replace Charging for Investigational...

On 22-July 2022, USFDA released multiple guidance among them one is "Orange Book Questions and Answers Guidance for Industry. What is...

On 2 June, an official Q&A prepared by the European Commission (EC), European Medicines Agency (EMA), and the Heads of Medicines Agencies...

Yesterday, FDA issued a Small Entity Compliance Guide to help small businesses comply with the final rule on importation of prescription...

Interviews are tough! At least people like me, have always struggled to answer in interviews. Whatever or How much ever we prepare, we...

US Food and Drug Administration on 17th September, 2021 finalized additional questions and answers related to biosimilar development and...

On 8th September 2021, FDA issued this guidance to provide general recommendations to prospective applicants and applicants of...

FDA announced the availability of a final guidance for the industry entitled "Field Alert Report (FAR) Submission: Questions and...

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