Life Science Compliance Update

May

2018

The Wheels of Time Grind Slowly – FDA Issues Draft Guidance For Compound Pharmacy Outsourcing Facilities

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Carolyn Greene

In response to concerns about the safety of compounded drugs, particularly those produced in bulk, Congress passed the DQSA which amended the FFDCA to create a new category of compound pharmacies referred to as “outsourcing facilities.” Outsourcing facilities are subject to heightened FDA regulatory authority compared to traditional compound pharmacies. The FDA has just issued a Draft Guidance outlining some of the new regulations relevant to outsourcing facilities. These regulations limit the drugs that outsourcing facilities may produce in bulk quantities.


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May

2018

The Intersection Between Patients, Health Information And Devices – New FDA Guidance Attempts To Prevent A Traffic Accident

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Gwendolyn Ball, Staff Writer, Life Science Compliance Update

The rapid of expansion of connected medical devices producing patient-specific health information is the focus of a new FDA guidance document. This article explores the requirements in the guidance and what impact it might have on medical device manufacturers.


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April

2018

The End of Guidance Documents or Simply a Reminder of Well-Established Administrative Law Principles

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Kaitlin Fallon Wildoner, Esq., and Seth B. Whitelaw, J.D., LL.M, S.J.D.

As discussed in several news outlets, the Trump Administration recently announced that it would begin to enforce long-standing administrative law principles and limit the weight guidance documents carry in government actions against private companies and individuals. While the ramifications of this decision are still months away from realization, this article outlines the principles and the possible effects we will see in the future from this decision.


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