A Grain of Potassium Chloride Salt (May 21, 2019 22:44)
By Riëtte van Laack —

Holidays and Red Herrings: FDA’s “Nonenforcement Discretion” Successfully Challenged (May 20, 2019 22:13)
By Douglas B. Farquhar —

In an Unusual Administrative Law Development, DOJ’s OLC States That FDA Has No Regulatory Authority Over Articles Used in Lawful Executions (May 19, 2019 22:52)
By Kalie E. Richardson —

Federal Court Punts Regarding Remedy Related to CMS’ Invalidated Rule Concerning Medicare Hospital Outpatient Payment Rates for 340B Drugs (May 16, 2019 22:48)
By David C. Gibbons & Alan M. Kirschenbaum —

Anything You Can Do I Can Do (Better?): Demonstrating Biosimilar Interchangeability (May 16, 2019 04:45)
By Sara W. Koblitz —

FDA Finalizes Guidance on Non-Clinical Bench Performance Testing Information in Premarket Submissions (May 14, 2019 22:31)
By Adrienne R. Lenz, Senior Medical Device Regulation Expert —

Brave New Real World: FDA Draft Guidance Takes First Steps to Move RWE from Dystopia (May 13, 2019 22:26)
By Larry J. Bauer, Senior Regulatory Drug Expert & James E. Valentine —

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