Regulatory

These resources are focused on regulatory policy regarding of long-acting antiretrovirals

Getting Started with the Division of Antiviral Products Pre-IND Process

Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA.