Publications

Hogan Lovells Publications

A new normal in the pharmaceutical industry: How to fight back when your competitor can't stop fibbing

Center for Drug Evaluation and Research (CDER) Director Janet Woodcock, M.D., recently indicated that the Food and Drug Administration (FDA) is unlikely to take enforcement action against a ...

Hogan Lovells Publications

FDA pushes "consumer-friendly" presentation of quantitative data in DTC promotions

On Tuesday, the Food and Drug Administration (FDA or the agency) published a draft guidance document, "Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer...

Hogan Lovells Publications

New anti-kickback prohibition in opioid bill creates tangled web of compliance obligations

On October 3, the U.S. Congress passed H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the SUPPORT...

Hogan Lovells Publications

FDA schedules public hearing on solutions to drug shortages

The U.S. Food and Drug Administration (FDA) has announced it will hold a public meeting on November 27 in Washington, D.C. to give stakeholders – including health care providers,...

Hogan Lovells Publications

New pharmaceutical technologies usher in significant changes to liability laws

As more pharmaceutical manufacturers introduce digital components to their products, the industry is beginning to consider long-term implications around liability issues.

Hogan Lovells Publications

Crackdown coming? Draft guidance suggests FDA is looking more closely at clinical trial disclosures

On Friday, September 21, the Food and Drug Administration (FDA) published a draft guidance titled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank."

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

China drug regulator calling on international pharmaceutical companies to bring “urgently-needed” new drugs to China

On 8 August 2018, in an unprecedented regulatory action, the China National Drug Administration (CNDA) called on international pharmaceutical companies to bring 48 new drugs to China. These ...

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