Publications

Hogan Lovells Publications

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

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

FDA finalizes 3D printing guidance

On December 5, 2017, the U.S. Food and Drug Administration (FDA or the Agency) finalized its “leapfrog guidance” entitled, “Technical Considerations for Additive...

Publications

FDA, EU regulators agree to share unredacted inspection reports and other confidential information

The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which...

Hogan Lovells Publications

HHS Overhauls the Common Rule to Enhance Protection for Human Subjects in Research

On 18 January 2017, as one of the last actions of the outgoing Obama Administration, the U.S. Department of Health and Human Services (HHS) and fifteen other federal agencies (the Agencies) ...

Publications

"Institutional Review Board (IRB) Written Procedures" Draft Guidance and NIH's "Single IRB Policy" Offer Food for Thought to IRBs Charged with Oversight of Human Subjects Research

Last week, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS) issued joint draft...

Published Works

Navigating Through a Complex and Inconsistent Regulatory Framework

The integrity of unbiased clinical data is essential to the future of the health care system by facilitating the discovery of lifesaving medicines and ensuring investigational drugs are...

Hogan Lovells Publications

Important New Steps in the Evolution of the Federal Policy for Protection of Human Subjects

On September 2, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a long-anticipated Notice of Proposed Rulemaking (NPRM) to overhaul...

Published Works

Comprehensive Legislative Reform to Protect the Integrity of the 340B Drug Discount Program

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