QMS for Virtual Companies
In today’s market, many biotech and medical device companies start off as a virtual or semi-virtual operation to keep fixed costs low. Virtual companies are run by a very small team, often one or two founders. With the rise of contract research organizations (CROs), contract manufacturing organizations (CMSs) and laboratories, most validation experiments right through […]
Reality check on 505(b)(2) NDA Approval Pathway
In 1984, the 505(b)(2) approval pathway was created to permit FDA approve new drug applications (NDAs) based on data from previously approved drugs and therefore streamline the development and approval process of new drug applications (NDAs). The 505(b)(2) pathway is very attractive to drug makers because it can shorten their development and cost timelines. Additionally, […]