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On December 23, 2015, the Food and Drug Administration's (FDA) released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base.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companies have spent millions of dollars issuing recalls for products because of a variety of quality issues caused by outdated manufacturing technologies.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
- 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
- Medicaid Behavioral Health Investigations and Payment Suspensions in D.C. Are Increasing – How Providers Can Limit Risk
- ‘Emilie’ Is Not a Psychiatrist: Pennsylvania Board of Medicine Alleges Unlawful Practice of Medicine by an AI Chatbot