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Hogan Lovells Publications

Just in time: FDA finalizes guidance on assessment of abuse potential of drugs

On 17 January 2017, just in time to evade the president's Regulatory Freeze Memorandum, the Food and Drug Administration (FDA) announced the availability of a final guidance entitled "Assess...

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Don’t Blink: 9th Circuit Issues Pivotal Decision on Enforcement of CSA Against Cannabis-ness

As reported here, earlier this month the U.S. Drug Enforcement Administration (DEA) issued a decision declining to transfer marijuana out of Schedule I.  As marijuana remains a Schedule I...

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DEA Keeps Marijuana in Schedule I While Expanding Access for Research and Clarifying Rules on Hemp

Yesterday, the U.S. Drug Enforcement Administration (DEA) took a number of actions regarding the federal control of marijuana, including denying a citizen petition to transfer the substance ...

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FDA Notifies Applicants of Intent to Require Sweeping Changes to Labeling for IR Opioid Analgesics and Entire Class of Prescription Opioids

FDA has announced its intent to require new class-wide labeling requirements for immediate-release (IR) opioid pain medications including new black and other safety warnings.  The enhanced...

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FDA Publishes Draft Guidances and Memorandum of Understanding on Drug Compounding and Repackaging

On February 13, 2015, FDA issued four draft guidance documents and a draft memorandum of understanding (MOU) regarding the compounding of drug and biological products and the regulation of...

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