Could FDA be made into an independent federal body?

Former FDA commissioners recently gathered at the Aspen Ideas Festival’s Spotlight Health discussing ways to minimize bureaucratic and political red tape.  FDA’s science based recommendations of safety and efficacy of food and drugs many times have political pressures...

cGMP clinical grade stem cells

Outsourcing-Pharma.com’s Melissa Fassbender recently posted an article on a talk she had with James M. Anderson, M.D., Ph.D., Deputy Director, NIH Division of Program Coordination, Planning and Strategic Initiatives. This exchange reveals information on clinical grade...

Reminder of eCTD Deadlines Approaching

A reminder that Electronic Common Technical Document (eCTD) deadlines are approaching. All submissions to the FDA including NDA, ANDA, BLA and DMFs are required to be submitted in eCTD format beginning on May 5, 2017.  IND submissions are required to be submitted in...