Tag Archives: FDA Guidance

One Immediate Impact of President Trump On The FDA

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

HDA’s 2016 Serialization Readiness Survey

Because of all the major news and developments over the last six months, it has taken me way too long to fully cover the Healthcare Distribution Alliance’s (HDA’s) 2016 Serialization Readiness Survey of drug manufacturers.  In my defense, I did cover it partially in my report of the HDA 2016 Traceability Seminar (see “HDA Delivers Home Run To Record-Breaking Audience”), but the other news from that event seemed to overshadow the survey results.  The HDA survey executive summary was so well done, and the results so important that it deserves closer scrutiny.  So here is my coverage, better late than never. Continue reading HDA’s 2016 Serialization Readiness Survey

FDA Finalizes Guidance On Suspect Product

suspect-product-final-guidanceHere we are, waiting for the FDA to publish new draft guidance related to the Drug Supply Chain Security Act (DSCSA) after a deadline that passed more than a year ago, and what do we get?  A final version of a guidance document that was originally published in draft form two and a half years ago:  “Identification of Suspect Product and Notification”.  Well, OK, thanks. 

I have to say, this is important guidance.  In fact, it is probably the most important DSCSA guidance that the FDA has published yet, whether in draft or final forms.  And, unfortunately, Continue reading FDA Finalizes Guidance On Suspect Product

5 Myths About The DSCSA In 2023

istock_67972853_smallerThere are a number of misconceptions floating around the industry right now about what will happen in November of 2023, when the Enhanced Drug Distribution Security (EDDS) phase mandated by the Drug Supply Chain Security Act (DSCSA) begins.  It is surprising where you hear some of these, but they are all based on mis-reads of the DSCSA law itself.  I’ll explain the myths, and then I will try to provide extracts from the DSCSA that expose them as myths. Continue reading 5 Myths About The DSCSA In 2023

Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?

Last week I wrote about the recent FDA DSCSA Public Meeting where the FDA asked for reports on the progress of the industry toward meeting the November 27, 2017 serialization requirements contained in the Drug Supply Chain Security Act (DSCSA) (see “FDA Forfeits Opportunity To Guide Industry”).  In that essay I expressed a view that the FDA has squandered too much of the time necessary for the industry to meet whatever guidance they might offer about grandfathering and exceptions for products that are too small to accommodate a DSCSA product identifier.  These guidance documents are now 11 months late.

What if the delay in publishing these guidance documents is intentional? Continue reading Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?