Mutagenic Impurities in a 505(b)(2): Why a Known API Does Not Mean Known Impurities
Few issues can quietly derail a 505(b)(2) NDA like a mutagenic impurity question. It may begin as a QSAR flag, a structural alert on a degradant, or a late request for toxicological support. Because the work can involve method development, validation, testing, and sometimes an additional study, a question raised in month six can still […]
Non-Clinical (animal) IND Enabling Studies: What You Need to Know
In drug development, IND enabling studies serve as a vital link between drug discovery research and the start of human clinical trials. These studies are used to compile evidence which shows a New Chemical Entity (NCE) is safe and effective before it is tested on people. Generally, they are also needed for 505(b)(2) product development, especially when a […]
The FDA’s 505(b)(2) Explained
Pharmaceutical innovation can stem from a variety of different facets in the industry. Healthcare providers and practicing physicians think of new concepts through observational data from their daily practice to suggest new, improved treatment solutions using existing approved medicines. From a similar vein, university researchers study the existing molecules of active pharmaceutical ingredients (API) in […]