Newsletter - April 5, 2018
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
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
