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Washington State Gov. Jay Inslee has signed legislation allowing pharmacists to substitute biosimilars for brandname biologics, joining a growing list of states that have passed such laws. Read More
Ranbaxy is being accused in federal court of filing ANDAs with false documentation in an effort to block generic competitors from coming to market. Read More
The FDA wants to know how patient perceptions of medications change when pharmacies switch from brand to generic drugs or from one generic to another, as in the case of a new supplier. Read More
The FDA wants biosimilars makers to retain for at least five years reserve samples of products used in comparative pharmacodynamic and pharmacokinetic studies intended to support an ANDA. Read More
Generics makers are asking the European Commission to clarify new requirements for factory acceptance and site acceptance testing, including the number of batches that need to be validated when bracketing is applied. Read More
The FDA is hoping that a study of spousal communication related to direct-to-consumer prescription drug advertising will help it make better recommendations for these ads. Read More
The FDA plans to issue a proposed rule this year streamlining requirements for fixed-dose combination prescription and over-the-counter drugs into one set of regulations, according to an updated list of priorities released Friday. Read More