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.
After years of pressure from lawmakers and drugmakers, the Obama administration appears to be surrendering its push for a reduced seven-year exclusivity period for biologic drugs. Read More
In an effort to head off one of the most common problems that sidetracks ANDA submissions, the FDA is telling drugmakers that bioequivalence studies for most drugs submitted as ANDAs should use a two-period, two-sequence, single-dose, crossover study design. Read More
In a boost for Big Pharma, the European Medicines Agency (EMA) has raised the fee-reduction rate for non-small and medium-sized enterprises (SMEs) seeking assistance on non-pediatric-related protocol from 40 percent to 75 percent, in line with recommendations by the agency’s orphan medicinal products panel. Read More
Admitting generic drug users are caught in a catch-22, a federal appeals court has dismissed liability suits brought by patients that took the generic version of Reglan (metoclopramide). 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
With EU lawmakers and the European Council expected to reach a compromise on clinical trial regulations before Christmas, pharma, researchers and patient groups are asking for assurance that timelines for trial data submissions are predictable and no longer than timelines currently in force. Read More
The biggest hurdle when trial investigators and staff are trying to build a good relationship with a study participant is managing their expectations, experts say. But there are some basic tips sites can use to overcome those hurdles. Read More
The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) have agreed to work together to help regulators and drug sponsors make the most of clinical and postmarket health data. Read More
New technology and anxiety over expiring patents have driven pharma to triple clinical development of large molecule and biologic drugs over the past decade, says an industry expert. Read More
The FDA and Vanda failed to agree on a prespecified primary endpoint for the new sleep disorder drug, tasimelteon, but that didn’t derail the company’s NDA. Read More
The FDA seems to have side-stepped many of the issues raised by industry in a draft guidance on preclinical considerations for gene/cellular therapies (CGT) while extending a guidance deadline for early-stage CGT development. Read More
In the latest initiative to clean up its troubled clinical trial industry, the Indian government is requiring investigators to video record the informed consent process for each subject in clinical studies. Read More