Shots: The US FDA has issued guidance to aid sponsors & IRBs for assuring the safety of participants in clinical studies, maintaining compliance with GCP and to reduce the risk […]readmore
Tags : Guidance
Shots: The company submitted report for the FDA’s guidance on Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products clarifying the clinical immunogenicity study for the approval of certain proposed […]readmore
Biosimilars
Biotech
Regulatory
The US FDA Releases Drafts Guidance Recommending on Comparative Analytical
Shots: The US FDA has released guidance on the design and evaluation of comparative analytical studies that are supporting demonstration of biosimilarity, with the withdrawn of previous draft guidance approach […]readmore