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OMB Seeks to Jettison Defense CAS Board and De-Couple CAS and TINA

Client Alert | 1 min read | 06.07.19

In late April, the Office of Management and Budget (OMB) sent a letter to Congress containing a number of legislative proposals to streamline and improve the federal acquisition process for inclusion in the Fiscal Year (FY) 2020 National Defense Authorization Act (NDAA). Two of those proposals relate to the Cost Accounting Standards (CAS). The first calls for the disestablishment of the Defense CAS Board—which was a product of the FY 2017 NDAA—to avoid creating a more complicated CAS regulatory framework. The second would de-link the monetary threshold for CAS from the Truthful Cost or Pricing Data threshold (formerly known as TINA), and increase the basic threshold for CAS applicability from $2 million to $15 million. These are two recommendations that the Section 809 Panel made in Volume II of its Report (the CAS Board is also considering repeal of the provisions establishing the Defense CAS Board and increasing the CAS applicability thresholds).

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FDA Announces Availability of ICH Draft Guidance on Inclusion of Pregnant and Breastfeeding Women in Clinical Trials

On Monday, July 21, 2025, the Food and Drug Administration (FDA) issued draft guidance entitled “E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials” from the International Council for Harmonisation of Technical Requirements for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....