Tag Archives: RAPS

DSCSA, FDA Guidance

InBrief: Why The DSCSA Will Be Enforced Even Without FDA Guidance

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As you are already well aware, the FDA is long overdue to publish four different guidance documents covering various aspects of the Drug Supply Chain Security Act (DSCSA), as mandated by Congress (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”).  At least two of those guidance documents would affect how companies should expect to comply with the serialization deadline on November 27, 2017. 

If the FDA doesn’t publish on or before that date, does that mean you don’t need to comply on time?  Can you just sit back and wait for the FDA to post those guidance documents someday?  I don’t think so.  Here’s why. Continue reading InBrief: Why The DSCSA Will Be Enforced Even Without FDA Guidance →

Brexit

How Brexit Might Impact The Pharma Supply Chain

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iStock_94550925_smallerA revolution occurred last week.  Not by guns—by referendum.  Like most revolutions, it caught a lot of people by surprise.  The most laughable surprise comes from those who voted for the UK to leave the European Union as a kind of protest vote, but immediately became sorry they voted that way after learning that they had “won”, because they really didn’t mean it!  It’s also laughable to hear the cries of the people who didn’t bother to vote because they felt confident that the referendum would go their way.  Now they would like to go back in time so they can cast their vote.  Whoops, too late.

What these people didn’t realize is that revolutions are serious business, whether executed with guns or with votes.  One of the reasons Continue reading How Brexit Might Impact The Pharma Supply Chain →

Healthcare Legislation

RAPS Explains The 21st Century Cures Act

House Engergy and Commerce CommitteeAlexander Gaffney, RAC, Manager, Regulatory Intelligence at the Regulatory Affairs Professionals Society (RAPS) is right on top of any new proposed legislation related to FDA and other health-related federal government agencies.  Last week he reported on the contents of a discussion draft of the “21st Century Cures” Act that was made public by the House of Representatives Energy and Commerce Committee (see Gaffney’s “Regulatory Explainer: The 21st Century Cures Act”).

At 393 pages, the draft bill, if enacted in its current form, would Continue reading RAPS Explains The 21st Century Cures Act →