On December 23, 2015, the Food and Drug Administration's (FDA) released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base.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companies have spent millions of dollars issuing recalls for products because of a variety of quality issues caused by outdated manufacturing technologies.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
- Last Call for Comments on the Bipartisan Discussion Draft of the SUSTAIN Act: Shaping 340B for the Future
- Indiana Senate Enrolled Act 9 Requires Written Notice of Health Care Entities’ Mergers or Acquisitions
- Connecticut Bill Calls for Office of Health Strategy to Develop a Plan Regarding Private Equity Firms in Health Care
- Revised OCR Guidance Provides New Examples, but Raises More Questions, Regarding Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates
- FDA Releases Draft Guidance on New Dietary Ingredient Notification Procedures, Timelines