Business · 18/11/2015

FDA Announces Guidance for Industry on Formal Meetings with Biosimilar Biological Product Sponsors or Applicants

The Food and Drug Administration (FDA) has released a guidance document providing recommendations for formal meetings between the agency and sponsors or applicants of biosimilar biological products, which are regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidance finalizes a draft document issued on April 1, 2013.