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The Top FCA Developments of 2022

Client Alert | 1 min read | 03.08.23

2022 was a busy year for the False Claims Act.  While recoveries were down, new cases reached a record mark, and settlements addressed multiple important and developing enforcement areas, from cybersecurity to small business fraud, bid rigging, Trade Agreements Act compliance, pandemic fraud, and more.  Of particular note, the U.S. Supreme Court held argument concerning the Government’s authority to dismiss qui tam actions, and it will soon hear consolidated cases as to the critical element of scienter.  And circuit courts issued key decisions involving pleading standards and merits issues.  These highlights and more are discussed by C&M attorneys in a “Feature Comment” published in The Government Contractor. 

Insights

Client Alert | 2 min read | 08.04.25

FDA Announces Availability of ICH Draft Guidance on Inclusion of Pregnant and Breastfeeding Women in Clinical Trials

On Monday, July 21, 2025, the Food and Drug Administration (FDA) issued draft guidance entitled “E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials” from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance is currently in Step 2 of the ICH process and open for public comment until September 19, 2025....