Dublin, July 21, 2021 (GLOBE NEWSWIRE) -- The "Trends: Hot Topic Catalyst" report has been added to ResearchAndMarkets.com's offering.
Receipt of a CRL slows approval, causing increased costs and lost sales, and may prompt withdrawal. The FDA Amendments Act (FDAAA) provided the FDA with new powers in relation to drug safety, including the authority to impose postmarketing requirements (PMRs) and Risk Evaluation and Mitigation Strategies (REMS) on drug manufacturers, which took effect on March 25, 2008.
The FDAAA has increased the costs of drug development due to a rise in post-approval spending: the average number of PMRs issued per drug was four in 2011 compared to two in 2008.
Complex REMS, which are issued relatively infrequently, require a significant investment from the applicant compared to REMS that only require medication guides and/or communication plans, and the impact on drug sales is almost certainly negative.
Key Topics Covered:
Overview of US drug approval regulations and procedures
Complete Response Letters and impact on approval
Take-home messages to avoid Complete Response Letters
REGULATIONS AND PROCEDURES OF RELEVANCE TO COMPLETE RESPONSE LETTERS
The FDA regulatory burden is increasing
US drug submissions process
COMPLETE RESPONSE LETTERS AND IMPACT ON APPROVAL
Trends in Complete Response Letters
FDA advisory committee meetings and Complete Response Letters
TAKE-HOME MESSAGES TO AVOID COMPLETE RESPONSE LETTERS
Common deficiencies that trigger a Complete Response Letter
Nucynta ER (tapentadol)
Menveo (meningococcal ACWY vaccine)
Horizant (gabapentin enacarbil)
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