FDA Focuses On Harmonization With The Launch Of Generic Drug Cluster
As Agency Calls For Scientific And Regulatory Alignment Globally
To improve common standards for global development for generics and access to generics, FDA has launched the Generic Drug Cluster through the Global Generic Drug Affairs team established by the FDA’s Office of Generic Drugs. The agency has listed objectives through which it aims to increase scientific alignment among leading generic drug regulatory agencies.
You may also be interested in...
Regulators hope parallel scientific advice pilot for complex generics is more popular than brand program was at start; sponsors want use of foreign comparator products and tighter harmonization.
Aset of “internationally harmonised guidelines on scientific and technical standards for generic drugs” should be developed through the International Council forHarmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), according to a proposal that has been put forward by the US Food and Drug Administration (FDA).
Kelix bio has announced two deals to expand its presence in Africa. The company is set to acquire 14 oncology injectable products from Germany-based Vitane. Furthermore, Kelix has acquired Pharmaceutical Institute, a pharmaceutical company established in Rabat, to enter Morocco. The pan-African company has also invested in Malta.