Before initiating a first-in-human clinical trial involving an unapproved drug, the sponsor is required to submit an application to the FDA for an Investigational New Drug (IND) exemption. This exemption authorizes the use of the unapproved drug in the trial without the need for a prescription.

Which category of New Drug Application (NDA) submission is required when a change in inactive ingredients necessitates bioequivalence or clinical studies?

Rapid renal clearance is one of the pharmacokinetic challenges of siRNA drugs.

An Established Pharmacologic Class (EPC) is associated with any potential indication for an active moiety, even if it is not approved by the FDA.

Which of the following is an advantage of RNA-based drugs?

A drug granted Breakthrough Therapy designation is entitled to all benefits associated with the First-in-Class designation

Lorena Hickock (the love interest of Eleanor Roosevelt) sometimes called the First Lady ___________ in letters.  

The politician used in the Truman lecture to demonstrate the transition of Democrats from social conservatives to social liberals was…

Who turned in Julius and Ethel Rosenburg to the authorities?

One of the last people that Joseph McCarthy accused of being a communist before he was publicly discredited was an Army ________.