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Federal Circuit Extends 'Good Faith' Shield of Agencies

Client Alert | less than 1 min read | 08.12.13

In Croman Corp. v. U.S. (July  31, 2013), the Federal Circuit upheld the reasonableness of an agency's corrective action after expanding the protestor's argument into a "bad faith" allegation. When the protestor complained that the cancellation of several CLINs was without a rational basis and put forward evidence that indicated the agency's rationale was pretextual, instead of requiring the agency to put forward proof to support its stated rationale, the court relabeled the challenge as a "bad faith" allegation, which it held the protestor had not shown by clear and convincing evidence.


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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 .  ...