Does the 505(b)(2) Regulatory Pathway for NDA's Provide an Adequate ROI?
I have a post on LinkedIn where I share a few thoughts about the benefits and limitations of developing drugs using the 505(b)(2) regulatory pathway. Hardly a week goes by without a pharmaceutical company expressing the desire to reap the benefits of developing a drug using the “505(b)(2) regulatory pathway”. What are 505(b)(2) new drug applications (NDAs) and do they really provide a meaningful advantage to pharmaceutical companies?
For the full post on LinkedIn, please see: http://tinyurl.com/j9fh2zn
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