Last Friday was the deadline for the FDA to publish four new guidance documents under the Drug Supply Chain Security Act (DSCSA) (see “Decoding The FDA’s DSCSA Timeline”).  The deadline was established by the U.S. Congress when they enacted the legislation and it was signed by President Obama on November 27, 2013 (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”).  But time spent by the FDA to meet their obligations under the DSCSA is “unfunded”.  That is, Congress did not provide any specific additional money to pay for the FDA’s new obligations under the DSCSA.  It is an unfunded mandate.

Fortunately the FDA is Continue reading FDA DSCSA Deadline Passes Quietly →