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November 20, 2014
Ralph G. Neas, president and CEO of the Generic Pharmaceutical Association, requests that Congress get involved in the support of a more competitive drug market.
November 02, 2014
Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.
November 01, 2014
The European Union takes the lead in a global pilot project on the marketing approval of generic medicines, highlighting the challenges of achieving consensus among different nations.
October 06, 2014
The total market for biopharmaceuticals in 2013 was $36.8 billion according to Kalorama Information. Meanwhile, Frost & Sullivan estimates that the biosimilars market, which it pegged at just $1.2 billion in 2013, will grow to $23 billion in 2019, or more than 20-fold increase.
October 02, 2014
Regulatory agencies in Europe are working to harmonize the marketing approval pathway of generic medicines.
September 16, 2014
A GPhA report says generic drugs saved the US health system $239 billion in 2013.
September 01, 2014
A surge in generic drug applications is testing FDA?s ability to reduce the backlog of ANDAs.
August 15, 2014
Concerns about quality in overseas production may bring generic drug production back to the United States, concludes CPhI study.
August 07, 2014
The European system for assessing drugs will be used as a model internationally.
August 02, 2014
FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.