What to Know
Informing the medical community and potential patients about a new drug therapy requires strategic planning. The FDA in the United States, Health Canada, and the EU’s MDR, along with other regulatory bodies, must control that messaging to ensure ethical and accurate information is presented, including risks.
Missing the mark for any aspect of prescription drug advertising and promotional regulations can be a detrimental (and costly) mistake.
I3 Infotek product labeling and promotion experts work in this specialty day in and day out. We can help ensure that your company has compliant, effective product labeling, promotional messaging, and ad campaigns. Protect your drug from misbranding, with advertising expertise you can trust.
How We Can Help
I3 Infotek regulatory promotional consultants know industry regulatory requirements of what is safe-harbored, for example. We understand critical needs for on-label and content that could raise scrutiny for off-label red flags. We know the nuances of prescribing information and benefit-risk balance for a successful launch and sustainable future path. Some of the advertising and promotional support our experts can provide includes:
- Create and author compliant pharmaceutical advertising and promotional content
- Manage, prepare, and submit required applications
- Assess print, broadcast, and reminder ads for regulatory compliance
- Risk disclosure requirements
- Interaction with CDER, OPDP
- Manage electronic and non-electronic submission requirements for human prescription drugs
- FDA 22253 submissions
- Remedial amendments (previously missing or rejected content)
- Warning responses and withdrawal requests