Tag Archives: generics
By Jill Wechsler | Published: August 20, 2014
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 […]
By Guest Blogger | Published: May 22, 2014
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 […]
By Pharm Exec | Published: March 28, 2014
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.
By Reflector | Published: March 10, 2014
The plan to accelerate generic pricing and reimbursement has become another tragic European casualty, writes Brussels correspondent Reflector.
By Pharm Exec | Published: January 24, 2014
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 […]