Eisner Safety Consultants Proudly Announces Launch of New Website Eisner Safety Consultants; a leading name in providing regulatory, quality system, and product safety consulting for the medical, in-vitro diagnostic, and hi-tech industries; proudly announces the launch of its revamped and
Leo Eisner Speaking at IEEE PSES ’09 Conference
Leo Eisner to present a regulatory update on IEC 60601-1, 3rd edition, at ’09 IEEE PSES Conference, Medical Track On October 27, 2009, Leo Eisner, of Eisner Safety Consultants and the Chair of the Medical Track for this Symposium, will
FDA New Procedures for Trial Investigators
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Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications A draft guidance has been issued for comment purposes only, see “Draft Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications” issued