PATIENT PACKAGE INSERTS (PPIs)
Every product should have an FDA-approved Patient Package Insert that is based on the Professional Labeling. Consumer Health Information Corporation has years of expertise in developing patient labeling for submission to FDA as part of the NDA.
Client: Pfizer, Inc.
Patient Package Inserts (PPIs) are FDA-approved “consumer-friendly” summaries of patient information for their products.They should serve as the foundation for the patient information programs developed for the product. This includes all patient information programs for the product launch, the patient website, and content for smart phone apps and other electronic delivery methods. They can also be published as patient information to help reinforce the product’s Direct-to-Consumer (DTC) programs.
Click here for more information on Patient Package Inserts.
Our Competitive Edge
Here’s why our clients keep coming back:
- The PPI must be based on the FDA-approved Package Insert. The Consumer Health team has been involved in many clinical trials and knows how to accurately interpret the research findings.
- Our team has advanced education and practical experience in biopharmaceutics and pharmacokinetics, clinical pharmacology and therapeutics, adverse drug reaction reporting, clinical evaluation of drug interactions, and administration techniques.
- We know what patient information in the Professional Package Insert must be included in the PPI so that it meets the needs of the patient, the product team and the FDA.
- Once we have evaluated and selected the information to include in the PPI, we translate it into language patients can understand!
- We take the extra step to improve patient compliance (and decrease home medication errors) by incorporating behavior modification techniques.
- Our clinical accuracy is unmatched. Clients are provided complete documentation and rationale for every statement using our unique DocuSource process.
- The Consumer Health team of clinical and patient education experts has the experience to meet face to face with your internal review committee. This eliminates the need to continually circulate drafts for comment. It also ensures that any proposed rewording from medical, legal, regulatory, marketing and consumer research is put into patient education language right on the spot. This saves you time and money.
- We know what is needed to meet FDA “fair balance” requirements. Our PPIs present risk information in language which does not frighten consumers.
- We have a track record of speedy FDA approvals.
- Companies have saved millions of dollars in their DTC advertising campaigns by using our expertise. Our PPIs meet all the requirements and still fit on one page!