Can President Trump, HHS Secretary Azar and Acting FDA Commissioner Sharpless eliminate/adjust/reinterpret any part of the Drug Supply Chain Security Act (DSCSA) to allow Florida, Colorado, Vermont, Maine or any other US state or territory to import drugs from foreign markets? Let’s take a closer look at what’s been going on recently with the idea of importing drugs from other markets in an attempt to help American citizens buy them at a lower cost.
Back in February I noted the steep drop in public inspection documents posted by the FDA immediately after President Trump took office (see “One Immediate Impact of President Trump On The FDA”). For that essay I created a graph that clearly showed the steep drop. But that was only one month after the new President took office. What has happened since then? This week I updated my graph so we can see how things are progressing. Continue reading Two-For-One FDA Guidance Docs→
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.
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
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