Tag Archives: licensing

FDA Guidance

Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?

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Happy Martin Luther King Day!

Congress set the calendar for many different kinds of requirements when it adopted the Drug Supply Chain Security Act, signed by the President back on November 27, 2013.  One of those dates was last November 27, 2015, two years after enactment, when the FDA was required to publish four new draft guidances.  So far, none of them have appeared (see “FDA DSCSA Deadline Passes Quietly”).  Continue reading Who Is Being Harmed By Four Overdue FDA DSCSA Guidances? →

ANVISA, FDA

More Thoughts On FDA and ANVISA

More ThoughtsOne of the problems with trying to respond overnight to big announcements made by regulators is that it’s easy to leave something significant out.  And in the ensuing days you find out what you should have included in those original essays.  That’s what happened with my two essays from last week:  “Brazil Suspends Pharma Serialization And Tracing Requirements” and “FDA Posts Wholesale Distributor and 3PL License Database“.

So let me add a few more thoughts and observations regarding Continue reading More Thoughts On FDA and ANVISA →

DSCSA

The New Draft Guidance On The Effect of Section 585 of the FD&C Imposed By The DSCSA

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Regulations.govThe FDA published draft guidance earlier this week that might seem a little confusing.  The full title is “The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements:  Questions and Answers.  Guidance for Industry”.  Because it is in “draft” form, it is published only to encourage people to submit comments about it.  (See also, “The Differences Between The DSCSA, FDA Rules and Guidance”.)

You should not treat it as real guidance until it is published in final form sometime in the future (if ever—many draft guidances are left handing in the breeze and never finalized).  As with all draft guidances, this one comes with a docket to provide the ability for people to leave comments to help the FDA figure out how to improve it before it becomes final.

The draft covers all of the topics that were contained in the Drug Supply Chain Security Act (DSCSA) Section Continue reading The New Draft Guidance On The Effect of Section 585 of the FD&C Imposed By The DSCSA →