Drug manufacturers developing OTC drugs have a lot of important decisions to make. One of these decisions is determining which regulatory pathway works best for their product.
Drug manufacturers developing OTC drugs have a lot of important decisions to make. One of these decisions is determining which regulatory pathway works best for their product. In this episode, Darshan discusses how the OTC monograph process takes...
There is growing pressure from patients to make healthcare more transparent. However, there remain privacy concerns about publicizing clinical research data.
Setting up effective, compliant investigational drug pharmacies means reviewing FDA requirements and applicable state boards of pharmacy. Depending on the regulatory body reviewing the pharmacy, different parameters may need to be met. In this...
The US Food and Drug Administration (FDA) issued a warning letter to stem cell clinics about releasing unproven treatments which posed high health risks to patients.