Regulatory Affairs

FDA Guidances Part of Charm Offensive to Woo Compounders

The flurry of FDA guidance issued this week explaining to compounders how to work with the FDA is part of the agency’s full-on effort to make registration as appealing as possible to compounders who may worry that regulatory oversight will hamper business. Read More

EMA Provides New Financial Perks for Large Orphan Drugmakers

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

Appeals Court Tosses Generic Reglan Case

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

FDA Sheds Light on Next-Gen Heart Drug Development Expectations

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

Light at End of Tunnel For EU Trial Regulations

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