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On December 23, 2015, the Food and Drug Administration's (FDA) released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base.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companies have spent millions of dollars issuing recalls for products because of a variety of quality issues caused by outdated manufacturing technologies.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 ...
Recent Updates
- DOJ, HHS Announce One-Stop Shop for Companies Voluntarily Disclosing Potential Health Care Fraud
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- Psychedelics Move Toward the Mainstream: Lawyers’ Bird’s-Eye View from the Horizons Conference
- CMS Receives Its Exclusion Authority: What Happens Now?
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