It is well known that, the Food and Drug Administration (FDA) has been working to implement the transition of biological products which are currently approved as drug products and are ‘deemed to be licensed’ as biologics under the Public Health Service Act on March 23, 2020.
Biological medicinal products have become the promising solutions in the prevention and treatment of several life-threatening, chronic diseases and health conditions. Realizing this scope, several pharmaceutical companies are venturing into producing biological products like never before.
July 30, 2018 Regulatory Labeling
Lack of clarity on indications and uninformed usage of drugs and biological products may lead to unforeseen adversities, which might in turn affect manufacturers / sponsors through financial penalties and legal actions.