The federal government entered into a partial shutdown at midnight on Saturday, December 22, 2018. The implications of the ongoing shutdown are far-reaching, but its impact on the Food and Drug Administration (“FDA”) is of particular concern to members of FDA-regulated industries and those with a role in ensuring the public health. Thousands of FDA

Last week both CDER and CDRH released a list of guidance documents they intend to develop or finalize over the next year.  However, it is interesting to note that the approach and information provided by each FDA center diverged significantly.  CDRH provided details as to the priority of guidances they plan on developing, offered specific