Hogan Lovells Publications

DEA launches new ARCOS enhancement to help manufacturers and distributors "know your customer" and detect suspicious orders Pharmaceutical and Biotechnology Alert

The U.S. Drug Enforcement Administration (DEA) announced last week that it launched a new tool for its Automated Reports and Consolidated Orders System (ARCOS) Online Reporting System that...

Hogan Lovells Publications

President signs 2018 Farm Bill with hemp reforms – implications for regulatory oversight of hemp-derived products including cannabidiol (CBD) Pharmaceutical and Biotechnology Alert

On December 20, 2018, President Donald Trump signed the Agricultural Improvement Act of 2018 (the 2018 Farm Bill) into law.

Hogan Lovells Publications

FDA finalizes two guidances clarifying DSCSA enforcement exemptions and issues product identifier Q&A Pharmaceutical and Biotechnology alert

Yesterday, the U.S. Food and Drug Administration (FDA) finalized two important Drug Supply Chain Security Act (DSCSA)-related guidances that aim to help pharmaceutical trading partners...

Hogan Lovells Publications

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

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...

Hogan Lovells Publications

Congress Enacts Comprehensive Addiction and Recovery Act of 2016 Pharmaceutical Alert

On July 22, 2016, the President signed the Comprehensive Addiction and Recovery Act of 2016 (Pub. L. No. 114-198) (CARA), an expansive law intended to address the prescription opioid abuse...

Hogan Lovells Publications

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

On February 13, 2015, the FDA issued four draft guidance documents and a draft memorandum of understanding (MOU) regarding the compounding of drug and biological products and the regulation ...

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