News about GMP/cGMP

The report further describes a number of programs that help ensure the safety of drug products and reports on key safety milestones achieved over 2015 and to date in 2016.

According to Janet Woodcock, M.D., Director of CDER, the report goes well beyond previously issued safety-related reports and offers a broader picture of FDA’s safety efforts. It takes into account the whole product lifecycle as envisaged by CDER/FDA and gives an insight into how the FDA operates and where emphasis is being laid on.

Source:

FDA: Drug Safety Priorities 2015-2016