Pharmacovigilance

A term that can be applied to the entirety of drug safety oversight, including pre-approval and post-marketing periods.

 Drug Safety challenges differ substantially between early development (Phase 1, 2), late stage clinical trials (Phase 3), and the post-marketing period.  As expected, these differences are reflected in the concerns of the companies responding to the survey
CLICK HERE FOR THE RESULTS OF THE IND SAFETY FINAL RULE SURVEY

These nuances are fairly well known in industry drug safety circles.

What is less known however is the impact of FDA’s recent movements with respect to the IND Safety Final Rule: the June 2021 Draft Guidance:

Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.
CLICK HERE FOR GUIDANCE DOCUMENT
IND Final Safety Rule Survey
Dr Peg Fletcher Margaret Fletcher MD PhD

Dr. Peg Fletcher, industry recognized drug safety thought leader and driving force behind the early development drug safety CRO MedAssessment is honored to be invited by DIA to present a poster to:

European DIA Annual Meeting
 29-31 March, 2022
Brussels, Belgium
CLICK HERE FOR THE RESULTS FROM OUR IND SAFETY FINAL RULE SURVEY
Among the potential impacts of the Draft Guidance are:

New requirements for analysis of aggregate safety data during active study conduct
Considerations with respect to how to include unblinded data in the aggregate analysis
Incorporation of epidemiology studies, and impact on rare disease and other indications for which 
copious epidemiology data may not be available
Defining event vs. toxicity
Defining benchmarks for anticipated events
Creation of a safety surveillance plan
Dealing with different requirements for FDA vs. other global health authorities.
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