The New FDA-Product Approval, Inspection, and Enforcement
The US Food and Drug Administration has recently released information about its new strategies as a result of the new administration.
The new commissioner recently announced a new policy for Warning Letters and FDA-483 responses, putting manufacturers under very tight response timelines. The CDRH director recently retired under a cloud of complaints from center scientists about device approvals being too friendly to manufacturers. More inspectors are taking to the field to attack the backlog of inspections, and FDA is once again pushing third party inspections as another strategy to reduce backlog. The commissioner is speaking about returning to the mission of the agency, protecting the public health, All of these changes bring uncertainty to device approvals and the ability of manufacturers to keep products on the market.
Areas Covered in the seminar:
Who Will Benefit:
- The "new" FDA organization and mission
- Enforcement changes- increased inspection
- Enforcement Changes-new expectations
- Manufacturers responsibilities for FDA-483s
- Manufacturers responsibilities in Warning Letter situations
- Pre-market changes-Human Factors
- New Risk Management Guidance
- Regulatory Managers
- Quality Managers
- Product Managers
- Project Managers