Publications

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 ...

Hogan Lovells Publications

U.S. House legislation highlights escalating government-wide focus on opioid abuse

On June 22 the U.S. House of Representatives passed sweeping legislation that represents "the biggest effort Congress has ever undertaken" to address the opioid epidemic, according to Rep....

Hogan Lovells Publications

FDA guidances promote greater communication to payors about medical product value

On June 12, FDA finalized two guidance documents regarding the types of information that drug and device manufacturers may communicate to payors and that the agency regards as...

Hogan Lovells Publications

FDA proposes streamlining combination product regulations

On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule...

Hogan Lovells Publications

A new right for American patients: The Right to Try

Hogan Lovells Publications

Patent law in Europe: What pharmaceutical companies need to know

With pharmaceutical competition in Europe continuing to evolve, established companies and new market entrants alike need to understand how key patent litigation tools are shaping the...

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