The Food and Drug Administration has openly commented on its objective to become more of a proponent and less of an obstacle for innovative pharmaceuticals and medical devices to enter the marketplace. However, the life science industry still views the regulatory approval process as a difficult path to navigate due to stringent requirements for clinical data, lengthy approval timelines and a lack of transparency from the FDA. To improve the relationship between manufacturers and the agency, a collaborative environment must be fostered through effective communication and an understanding of FDA's plans for transforming regulatory pathways into a catalyst for medical innovation.
Medical Device & Diagnostic Regulatory Breakout
- -Impact of Innovation Initiative within CDRH
- -Promoting innovation through high quality clinical science
- -Communication efficiency to reduce reviewer inconsistencies and speed up approvals