The FDA has recently initiated a pilot program which will help drug manufacturers use complex innovative trial designs (CID). This move comes after the agency committed to helping facilitate and advance the use of complex [...]
In a move that defies President Trump’s proposed budget for fiscal 2019, the Senate is gearing up to approve a $2 billion increase in funding for the National Institutes of Health (NIH). This increase has [...]
Earlier this week, the FDA approved potassium chloride oral solution which is the first generic drug to receive a Competitive Generic Therapy (CGT) designation. This new approval pathway has been created as part of the [...]
The US has had a hard time accepting biosimilar drugs, the copycat versions of biologics which are similar to the innovator product, but not exact replicas. To date, the FDA has approved only 11 biosimilar [...]