US FDA's Postmarket Study Requirements: Industry Wants Standardization, Expert Input
Executive Summary
PhRMA, BIO and Pfizer call for predictable process for setting postmarket commitments and requirements, periodic reevaluation of their necessity and feasibility, and FDA acceptance of novel trial designs.
You may also be interested in...
Sponsors Staying On Schedule With Postmarketing Requirements And Commitments
About 80% of drug sponsors were on track with post approval studies in FY 2017, US Food and Drug Administration notes in its annual report on performance of applicants.
FDA 'Consistency' Is Industry Watchword For Promoting Effective Drug Development
Pharma companies and associations cite numerous examples of getting inconsistent advice across review divisions, including the number of clinical trials required for rare disease drugs and acceptance of innovative clinical trial designs and novel endpoints.
Mandatory Efficacy Trials: US FDA Affirms Broad Scope Of New Post-Market Authority
Updated guidance on its authority to mandate postmarketing studies affirms that a new power to impose requirements to look for diminished efficacy reaches beyond the opioid drug class.