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Newsletter - April 5, 2018
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FDA’s Review Process Shows Preferential Treatment of NMEs for Unmet Medical Needs 

This week FDA posted a review of its drug approval process based on the principle of benefit-risk-assessment that shows it gives special consideration to new molecular entities (NMEs) intended for diseases with few or no treatment options with regards to market approval decisions....Read More

FDA’s Pre-Approval Inspection Matrices Show Interesting Trends

 

FDA recently published the time-lines for the pre-approval GMP inspections for drugs and medical devices and it shows some useful time-lines for regulatory actions that may be useful to all manufacturers planning for such inspections Prior to approval of any new drug....Read More

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