Food, Drugs, Healthcare, Life Sciences

The Food and Drug Administration (FDA) has provided small pharmacies with additional time to comply with certain enhanced drug distribution security requirements under the Drug Supply Chain Security Act (DSCSA).

The Department of Justice has issued its first healthcare fraud declination under the new Corporate Enforcement Policy, demonstrating that companies can avoid criminal prosecution by voluntarily disclosing misconduct, cooperating with investigators, and implementing compliance fixes.

Florida's Attorney General has launched an antitrust investigation into CVS Health and its pharmacy benefit manager Caremark, examining whether the company inappropriately steered patients to CVS pharmacies and reimbursed them at higher rates than independent pharmacies. The investigation, part of a broader multi-state scrutiny of PBM business practices, seeks documents and testimony on policies related to transparency, reimbursement rates, audits, and market concentration in an industry where three PBMs co

The U.S. Food and Drug Administration has proposed converting its voluntary GRAS notification program into a mandatory requirement, fundamentally changing how food substances enter the market. Companies would be required to submit GRAS notices for substances marketed under Generally Recognized as Safe provisions, with limited exceptions and a streamlined process for existing ingredients.

The FDA has issued revised draft guidance on demonstrating substantial evidence of effectiveness for drug and biological product applications, emphasizing when a single adequate and well-controlled clinical investigation combined with confirmatory evidence may satisfy regulatory standards. The guidance updates recommendations for meeting effectiveness requirements in new drug applications and biologics license applications, reflecting advances in biological understanding and data availability.

The U.S. Food and Drug Administration (FDA) proposed a rule that, for the first time, would require manufacturers to notify FDA of substances marketed for human or animal food use based on a conclusion that the substance is Generally Recognized as Safe (GRAS)

Amneal Pharmaceuticals has finalized its acquisition of Kashiv BioSciences for up to $1.1 billion, creating what the company describes as a fully integrated global biosimilars platform. The deal positions Amneal to launch multiple biosimilar products annually and capitalize on an unprecedented wave of biologic patent expirations in the coming years.

As global energy demand rises and pressure to decarbonise intensifies, biotechnology is emerging as a key driver of sustainable fuel innovation. This insight explores how advances in plant, microbial and algal biotechnology can support the transition to cleaner energy systems and contribute towards meeting United Nations Sustainable Development Goal 7.

The Department of Health and Human Services has unveiled Operation TrialBlazer, a comprehensive initiative to accelerate US-based clinical research and maintain American competitiveness in early-stage drug development. Meanwhile, FDA continues to shape the regulatory landscape through new guidance on psychedelic therapies, authorization pathways for generative AI medical devices, and planned rulemaking that could fundamentally alter prescription drug advertising requirements.