Pharmaceutical and biotech manufacturers using artificial intelligence (AI) to support compliance with Food and Drug Administration (FDA) regulations should take note: the lack of human oversight of AI quality tools can constitute a current good manufacturing practice (CGMP) violation.
As 2025 drew to a close, the Centers for Medicare & Medicaid Services (“CMS”) issued proposed rules for two mandatory pricing models aiming to reduce out-of-pocket costs for Medicare drugs.
On December 23, 2015, the Food and Drug Administration's (FDA) released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. This was a positive step towards helping pharmaceutical companies invest and implement emerging technologies that improve overall drug quality.
Pharmaceutical companies have spent millions of dollars issuing recalls for products because of a variety of quality issues caused by outdated manufacturing technologies. These issues have caused significant delays in providing ...
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Recent Updates
- Patent Infringement Lawsuit Alleges "Piracy" of AI-Driven Medical Technology
- DOJ Civil Division Accelerates Review of FCA Whistleblower Complaints Involving Federally Funded, State-Administered Benefits Programs
- FDA Warns Against “Over-Reliance” on AI Pharmaceutical Manufacturing . . . But How Much Reliance Is Too Much?
- Five Federal Cases Health Care and Life Sciences GCs Should Continue to Watch in 2026
- CMS Announces Nationwide Moratoria on New Medicare Enrollment for Hospices, Home Health Agencies