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 plans to mandate that manufacturers of antibacterial soaps and body washes submit clinical outcome study data that address safety and efficacy of their products, regulating them as they would other OTC medications. Read More
A new House bill aims to build on the success of the Generating Antibiotics Incentives Now (GAIN) Act by allowing drugmakers to submit less data for antibiotics and antifungals that affect limited patient populations. Read More
A new House bill aims to build on the success of the Generating Antibiotics Now (GAIN) Act by allowing drugmakers to submit less data for antibiotics and antifungals that affect limited patient populations. Read More
In a boost for big pharma, the European Medicines Agency raised the fee-reduction rate for non-small and medium-sized enterprises seeking assistance on adult-only protocol from 40 percent to 75 percent, effective Jan. 1. Read More
Generics makers should design tablets and capsules to be similar in size and shape to their reference listed drug (RLD) when they seek ANDA approval, the FDA says. Read More
Eli Lilly’s plans for strong sales growth in 2014 have been set back, with the drugmaker saying Thursday its promising depression treatment edivoxetine has failed in late-stage testing. Read More
While developers of next-generation heart drugs known as PCSK9 inhibitors will need to present data showing their effectiveness at lowering cholesterol, blood pressure and inflammation, they will not be required to show reduced heart attack or stroke, according to the FDA. Read More