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DoD Issues Class Deviation For Small Business Joint Venture Offerors Until SAM Is Updated to Account for Recent FAR Revisions

Client Alert | 1 min read | 10.27.22

On October 26, 2022, the Department of Defense published a class deviation establishing alternative procedures for verifying the small business size and status of joint venture offerors.  This class deviation is necessary because, effective October 28, 2022, the Federal Acquisition Regulation has been updated to include new certifications for use by joint venture offerors in FAR solicitation provisions 52.212-3 and 52.219-1—via a FAR update on which Crowell previously reported.  Due to a lag in system implementation in the System for Award Management (SAM) and in the interface between SAM and the Small Business Administration, SAM will not reflect the new representations immediately.  As such, DoD’s class deviation provides language for contracting officers to use in solicitations in lieu of relying on SAM for size and status certifications of joint venture offerors.

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Client Alert | 3 min read | 06.26.25

FDA Targets Gene Editing Clinical Trials in China and other “Hostile Countries”

In a somewhat ambiguous press release on Wednesday, June 18, 2025, the Food and Drug Administration (FDA) announced a halt and “immediate review” of new clinical trials where American patients’ cells are sent to China or other “hostile countries” for genetic engineering with the expectation that the cells will be infused back into U.S. patients.[1] A subsequent podcast published by the agency also said that therapies that involved cells that were sent to China for genetic engineering and intended for subsequent infusion into U.S. patients would not be approved going forward. The announcement said that there is “mounting evidence” that some clinical researchers failed to obtain informed consent from trial participants about the international transfer and manipulation of biological material....

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