Publications

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

On May 22, 2018, the U.S. House of Representatives passed Senate Bill 204, commonly known as the “Right to Try Act of 2017” by a vote of 250-169. The bill gives certain patients ...

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...

Hogan Lovells Publications

Administration presents plans to lower drug prices

On May 11, 2018, President Trump and Department of Health and Human Services (HHS) Secretary Alex Azar delivered highly anticipated speeches regarding the administration's plan to reduce...

Hogan Lovells Publications

China Drug Administration publishes a key Draft Guidance on data exclusivity for pharmaceuticals

This is the first time the China Drug Administration (CDA) provides details on how the data exclusivity applies to pre-clinical and clinical data submitted to the agency. Companies with...

Hogan Lovells Publications

Outlook for OTC drug regulation

Significant change is on the horizon for the over-the-counter (OTC) drug industry. OTC drug sales have grown from about US$3 billion in 1972 to over US$34 billion today, with over 300,000...

Hogan Lovells Publications

UK M&A: Brexit and investment in UK life sciences

While Brexit is likely to result in sweeping changes to the UK’s life sciences sector, the rate of M&A and foreign investment is a positive sign that the region will uphold its...

;
Loading data