Search


USFDA finalizes Q&As on Biosimilar Development
US Food and Drug Administration on 17th September, 2021 finalized additional questions and answers related to biosimilar development and...

Sharan Murugan
Sep 23, 20211 min read
Â
Â


USFDA's updated guidance on Development of ANDA During the COVID-19 Pandemic – Q&A -USA
On 8th September 2021, FDA issued this guidance to provide general recommendations to prospective applicants and applicants of...

Sharan Murugan
Sep 11, 20211 min read
Â
Â


Final Guidance - FAR Submission: Q&A – US FDA
FDA announced the availability of a final guidance for the industry entitled "Field Alert Report (FAR) Submission: Questions and...

Sharan Murugan
Jul 25, 20211 min read
Â
Â


FDA Guidance regarding Onsite Inspections during COVID19 (Q&A) - USA
After the publication of the Guidance for "Remote Interactive Evaluations", FDA has updated its "Manufacturing, Supply Chain, and Drug...

Sharan Murugan
May 28, 20211 min read
Â
Â
