North America: Food, Drugs, Healthcare, Life Sciences

The SEC and FDA have formalized an information-sharing agreement that fundamentally changes how life sciences companies must approach their public disclosures about FDA interactions. This memorandum of understanding creates a direct pathway for the SEC to access previously confidential FDA records, including meeting minutes and Complete Response Letters, to verify the accuracy of companies' public statements.

Two recent lawsuits claim supplement labels may mislead consumers by highlighting creatine content per serving on the front panel without clearly showing that a serving includes multiple gummies or tablets.

The U.S. Food and Drug Administration’s (FDA) recently released discussion paper on generative artificial intelligence (GenAI)-enabled medical devices may be as notable for what it does not say as what it does say.

AbbVie has submitted a regulatory application to the European Medicines Agency seeking approval for SKYRIZI (risankizumab) subcutaneous induction treatment for adults with moderately to severely active Crohn's disease. The application, supported by positive Phase 3 AFFIRM study data, follows a similar FDA submission and could provide patients with an alternative to intravenous infusion for their induction doses.

The American Chemical Society has announced the 2026 Green Chemistry Challenge Award winners, recognizing groundbreaking innovations across nine categories that transform how industries approach sustainability.

The SEC and FDA have formalized an information-sharing agreement that fundamentally changes how life sciences companies must approach their public disclosures about FDA interactions. This memorandum of understanding creates a direct pathway for the SEC to access previously confidential FDA records, including meeting minutes and Complete Response Letters, to verify the accuracy of companies' public statements.

AbbVie has submitted a regulatory application to the European Medicines Agency seeking approval for SKYRIZI (risankizumab) subcutaneous induction treatment for adults with moderately to severely active Crohn's disease. The application, supported by positive Phase 3 AFFIRM study data, follows a similar FDA submission and could provide patients with an alternative to intravenous infusion for their induction doses.

The Department of Justice declined to prosecute Campus Eye Management under its new Corporate Enforcement Policy after the healthcare company voluntarily disclosed Medicare fraud involving unnecessary diagnostic tests and kickback schemes. While the company avoided prosecution through cooperation and remediation, DOJ simultaneously indicted its founder and former CEO, raising critical questions about how healthcare organizations should balance voluntary disclosure, individual accountability, and compliance

State attorneys general in Florida and Louisiana have filed lawsuits against pharmacy benefit managers alleging collusion and price-fixing of reimbursement rates paid to retail and independent pharmacies. These cases represent a growing trend of states pursuing antitrust enforcement actions against PBMs for allegedly coordinating to suppress pharmacy reimbursements.