Publications

Hogan Lovells Publications

FDA finalizes guidances for NGS-based tests

On April 12, 2018, the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidances on the oversight of next generation sequencing (NGS)-based in vitro diagnostic tests....

Hogan Lovells Publications

Employment alert: April 2018

In this month's issue of our newsletter on employment matters in Poland:

Hogan Lovells Publications

Connecting Europe - False advertising in life sciences

In view of the success of our first edition of “False Advertising in Life Sciences”, we are proud to introduce our second edition which is even more thorough.

Hogan Lovells Publications

Seeking to reduce premarket burdens, FDA proposes to expand Abbreviated 510(k) Pathway for certain devices

Building on recent efforts to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft guidance seeking to expand use of the ...

Hogan Lovells Publications

CMS releases annual health insurance exchanges final rule

On April 9, 2018, the Centers for Medicare & Medicaid Services (CMS) released the Benefit and Payment Parameters final rule for 2019 (2019 Payment Notice) applicable to qualified health ...

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

What device companies need to know ahead of an advisory panel meeting

Preparing for advisory panel meetings
For companies that manufacture new and novel medical devices, advisory panel meetings can be a crucial step toward receiving formal clearance or...

Hogan Lovells Publications

Department of Defense FY18 research funding for the Congressionally Directed Medical Research Program

The Congressionally Directed Medical Research Program within the U.S. Army Medical Research and Material Command that is a partnership formed by Congress, the military and the manages...

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