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December 07, 2017
An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.
November 30, 2017
Experts slam drug prices and endorse government price negotiations and curbs on drug advertising.
November 27, 2017
Manufacturers and trading partners struggle to meet drug tracking requirements
November 07, 2017
The debate continues over biosimilar naming, interchangeability, and patent protection, as well as lingering concerns in the medical community about the safety of switching patients to new therapies.
While most pharma companies are in partial production using generators, few are operating at 100% capacity.
October 05, 2017
FDA and manufacturers strive to prevent drug shortages from Hurricane Maria.
September 25, 2017
Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.
August 28, 2017
High-priority issues requiring immediate attention leave little time for Congress to consider drug access proposals that have limited bipartisan support.
August 10, 2017
Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.
August 08, 2017
The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes.