Tag Archives: generics

Implementing the Generic Drug User Fee Act: Struggles and Successes

Two years into the Generic Drug User Fee Act (GDUFA) program, enacted in July 2012, FDA officials are striving to meet goals and timelines for speeding new generic drugs to market. Agency reviewers have made some progress in eliminating the huge backlog in abbreviated new drug applications (ANDAs) pending in the Office of Generic Drugs […]
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What MNCs Can Learn from Generics Companies

In the last three decades, MNCs have contributed greatly to the transfer of knowledge to generic companies in areas such as technology, marketing know-how, working methods, management techniques, R&D, and branding. However, now is the time that MNCs can also learn significantly from generic companies amid the changing global industry landscape. This evolution has enabled […]
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EGA Calls for Removal of Barriers to Generics in Europe

Adrian van den Hoven, Director General of the European Generics Association (EGA), this week called for the removal of barriers to generic medicines across the European Union.
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Europe: Whatever Happened to Faster Reimbursement for Generics?

The plan to accelerate generic pricing and reimbursement has become another tragic European casualty, writes Brussels correspondent Reflector.
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FDA Prohibits Another Ranbaxy Facility from Producing Drugs for US Market

FDA has reported that it notified Ranbaxy Laboratories, Ltd., on Jan. 23 that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. The Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January […]
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