Product licence safety information

For all these reasons, and more, marketing and clinical input on suitable formulations should be included in the earliest considerations of project feasibility, and it behooves the clinical researcher to be able to provide such input in an informed manner. Equally, we should understand the constraints, difficulties and regulatory ramifications that all of our colleagues experience, including those in the research pharmacy. At the end of the day, product licences are awarded and NDAs are approved typically after the resolution of at least as many questions about chemistry, manufacturing, and controls (for which read pharmaceutics ) as about clinical efficacy and safety. 

---