Posts tagged New Drug Application.
Blogs
2 minute read
On December 23, 2015, the Food and Drug Administration's (FDA) released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base.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companies have spent millions of dollars issuing recalls for products because of a variety of quality issues caused by outdated manufacturing technologies.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