New FDA Guidance Advances Pharma Manufacturing TechLaw360 January 8, 2016
Shilpa Prem, an Associate in the Health Care and Life Sciences practice, in the firm’s New York office, authored an article for Law30 titled “New FDA Guidance Advances Pharma Manufacturing Tech.” (Read the full version – subscription required.)
Following is an excerpt:
By the very nature of new, innovative technology, the FDA lacks experience reviewing such technologies, which in turn discourages pharmaceutical companies from pursuing such ventures. Given the time it may take for FDA to get comfortable with the technologies, such innovations may add significant time to drug application reviews. To address this, the FDA has initiated a new Emerging Technology Team (ETT), through the Center for Drug Evaluation and Research (CDER), to which pharmaceutical companies would be able to submit presubmission questions and proposals and obtain early engagement to work through the manufacturing design, development and required submission content.