Biotech Stocks

What is a PDUFA?

What is a PDUFA?

PDUFA is both a legislation and a procedure in the drug approval process. In terms of legislation, it is a law enacted by Congress which allows the FDA to collect fees from drug-approval seeking companies in order to partially finance the process of approval. In terms...
What are Clinical Trials?

What are Clinical Trials?

Clinical trials are stages of progressively larger clinical research on drug candidates on human participants, both healthy volunteers and patients. Their goal is to study the safety and efficacy of a prospective drug. Efficacy and safety play a paired but opposite...