FDA Announces Initiatives to Streamline Development Process

April 12, 2018 – The FDA has announced plans to ease the development of genetic and genomic-based tests and introduced guidelines designed to accelerate the submission process for investigational cancer drugs and biological products. The agency said in a statement that it had finalized guidances intended to spur “efficient development of a novel technology that scans a person’s DNA to diagnose genetic diseases and guide medical treatments.” The first, titled Use of … (leggi tutto)