FDA Speeds Process for Banning Bad Trial Investigators RAPS (In The News) – The US Food and Drug Administration (FDA) has developed new procedures to help speed the process for barring noncompliant clinical trial investigators from future research. The new
FDA Chief Talks Tough
FDA chief’s pledge signals tougher safety stance Associated Press article where the FDA Chief Talks Tough and talks about the CDRH Head Resigning, CDER Head Accused of Ethical Violations.
Draft FDA Guidance on User Fees
Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications A draft guidance has been issued for comment purposes only, see “Draft Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications” issued
Available at IEC Webstore soon …
Replaced or withdrawn publications available shortly from IEC Webstore Previously you had to order Replaced or Withdrawn IEC publications thru the IEC Central Office Customer Service Center. This changes should make the purchase of these documents quicker and easier.
EU MDD Recast in 2010
European Device Regs To Be Recast In 2010, With Separate IVD Revision EuroPharma Today.com article on the plans of the EU commission to overhaul the EU MDD in hopes of imposing a “modern set of rules” by 2015.