FavId Shows Promise
for relapsed NHL patients (The Pharm Voice)
In her blog, Gloria Gamat
discusses Favrille's recently announced results of a Phase II trial of its non-Hodgkin's
lymphoma (NHL) drug FavId.
Simplifying Global Compliance
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Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
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The implant allows for better imaging by minimizing material density.
Endo Resumes Lawsuit Against FDA Over Bulk Drug Compounding Decree
The company claimed the agency’s handling of bulk compounding laws violates the 2013 Drug Quality and Security Act, treating the laws as non-binding guidance rather than a legal mandate.