We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA warned an Indian manufacturer to immediately stop ignoring poor test results, the second Indian facility in a week to get a warning letter for data integrity violations. Read More
The FDA is creating a simple, one-step process for physicians to gain access to experimental drugs for patients facing terminal, untreatable conditions. Read More
Colorado lawmakers have introduced a biosimilar substitution bill that closely mirrors at least one aspect of compromise language unveiled by industry leaders in December — elimination of prescriber notification in favor of entering a switch into an electronic database. Read More
Actavis will become the UK’s largest generics supplier once its roughly $461 million acquisition of Auden Mckenzie closes in the first quarter of this year. Read More
The average price of generic drugs rose 4.9 percent in 2014, while prices for their branded counterparts jumped 14.8 percent, a new study finds. Read More
With the launch of the FDA’s Office of Pharmaceutical Quality, all ANDA filers are now eligible for OPQ’s real-time communications program — the quick-turnaround method the agency will use to resolve minor questions about chemistry, manufacturing and controls during ANDA reviews. Read More
The White House in its fiscal 2016 budget proposal Monday asked Congress to appropriate $486 million for CDER, a bump in funding of less than one percent, and $215 million for CBER, an increase of two percent. Read More
A federal judge has tossed out a liability lawsuit filed against brandmakers Wyeth and Alaven Pharmaceuticals, saying they were not responsible for the death of a patient who took generic Reglan not made by the companies. Read More