EMA Guideline on Computerised Systems and Electronic Data i...
04 Jul 2023
Lambda Therapeutic Research acknowledges the release of the European Medicines Agency - Good Clinical Practice Inspectors Working Group (GCP IWG)'s 'G...
Key takeaways from the FDA's draft guidance for Decentralize...
04 May 2023
A new Draft Guidance has been released by the FDA, which provides recommendations for sponsors, investigators, and other stakeholders on the implement...
EMA unveils the new features to enhance the PRIority MEdicin...
18 Apr 2023
To improve its PRIority MEdicines (PRIME) programme, which aims to hasten the development of medicines for unmet needs, the European Medicines Agency ...
Refuse to Receive Standards
02 Mar 2019
ANDA Submissions- "refuse to receive standards" Draft Guidance Prepared by: Mr. Bhavesh J. Rathod, Mr. Nishant R. Christian & Mr. Manoj K. Patel Ove...