On February 15, 2019, the U.S. Food and Drug Administration (“FDA”) finalized two guidance documents regarding regenerative medicine therapies (see FDA’s announcement here). This development comes nearly 14 months after FDA issued both guidance documents in draft form, which also coincided with FDA’s announcement of a new comprehensive regenerative medicine policy framework intended to spur innovation and efficient access to new regenerative medicine products.
FDA Commissioner Scott Gottlieb remarked that the finalization of regenerative therapy guidance ...
On December 23, 2015, the Food and Drug Administration's (FDA) released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base.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companies have spent millions of dollars issuing recalls for products because of a variety of quality issues caused by outdated manufacturing technologies.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 ...
Blog Editors
Recent Updates
- Proposed Modernization of the HIPAA Security Rules
- In Confirmation Hearings, AG Nominee Pledges to Defend the Constitutionality of the False Claims Act
- A Primer on Executive Orders and a Preview of the Road Ahead
- At Long Last, DEA’s Remote Prescribing Rules 2.0 Are (Really) Here! (Pending Further Consideration by the Incoming Administration . . .)
- Massachusetts District Court Applies “But-For Causation” Standard, Dismisses AKS-Based FCA Case After Evaluating Facts and Circumstances of Independent Contractor Arrangements