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IR&D Reporting Requirements Reinstated

Client Alert | 1 min read | 01.30.12

In a final rule published today, the DFARS were amended to reinstate a requirement that was eliminated from the regulations in the early 1990s, providing that as a condition of allowability for Independent Research and Development (IR&D) costs, major contractors must submit to DoD at least annually technical descriptions of the IR&D projects that the contractor claims as allowable. In response to criticism of a draft regulation proposing a $50,000 coverage threshold, the final rule limits mandatory reporting to “major contractors” that allocate more than $11 million annually to “covered contracts” (a term that excludes fixed-price contracts without cost incentives), leaves largely to the contractor’s discretion how much detail needs to be reported in the on-line template through which the reports must be submitted, encourages voluntary reporting by contractors not subject to the mandatory requirement, and promises that the reports will be exempt from disclosure under the Freedom of Information Act.

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Client Alert | 9 min read | 10.21.26

Artificial Intelligence in Life Sciences: Reliability of AI-Generated Evidence in Drug Discovery and Development

The life sciences sector is uniquely vulnerable to the inherent risks of AI-generated evidence in drug development and discovery. This client alert focuses on five core challenges: hallucinations, skewed predictions from unrepresentative training data, the opacity of AI reasoning, input sensitivity that undermines reproducibility, and adversarial manipulation of training data. To address these risks, companies should use experimental validation and human oversight as the common legal and regulatory safety net. This entails among other measures auditing AI outputs, characterizing training data, and structural oversight. Companies also should prepare for evolving frameworks and guidance from the U.S. Food and Drug Administration (FDA) and the European Union (EU) that address use of AI in drug discovery and development .  ...