Most RxTrace subscribers are aware that the FDA is way overdue to publish four guidance documents mandated by the Drug Supply Chain Security Act (DSCSA) (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?” and “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?” for a list of the missing documents). Two of those four documents could impact how some drug manufacturers deal with the November 27, 2017 deadline for full serialization of prescription drug products, depending on what the FDA says in them.
Every day since the original due date of those documents (November 27, 2015) I have Continue reading One Immediate Impact of President Trump On The FDA
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