FDA Patient Labeling

Patient Labeling, Patient Package Inserts (PPIs), Consumer Medication Instructions (CMI’s)

Patients Need Information They Can Understand”

“Patients need risk information that is non-threatening and understandable. Pharmaceutical companies need patient labeling that will help patients manage their medications safely and wisely. FDA requires that the patient labeling be evidence-based, 100% accurate and written in language the average patient can understand. We will work with your regulatory, medical, marketing teams to meet all these requirements. We will write the information at the Grade 6 – 8 level so that it is practical and meaningful to patients.”

– Consumer Health Information Corporation


Patient Medication Instructions The Brief Summary is meant for health professionals – not consumers! Consumers need good patient information about your product written in language they can understand.

Pharmaceutical companies are developing Patient Package Inserts (PPIs) for their products. Like Brief Summaries, PPIs discuss the risks and benefits of the product. But the PPI presents patient information in precise, understandable language developed specifically for consumers.

The FDA “believes that FDA approved patient labeling is a better vehicle for communicating risk information to consumers than lengthy, technical FDA-approved professional labeling.” ~FDA Draft Guidance, January 2004

Patient Labeling Done Right the First Time

Patient education

We have developed Patient Labeling for many of today’s top brands … successfully meeting the needs of patients, pharmaceutical companies and the FDA.

We have been invited to participate in many national think-tanks and worked with FDA and leaders of national organizations, healthcare decision makers, pharmaceutical companies, government and academia to determine the best ways to provide medication patient information.

  • Patient Labeling requires precision wording that is clinically accurate, “consumer friendly” and meets all of your marketing, legal and regulatory requirements.
  • All of our clients have received speedy FDA approval, saving them time and money.
  • We have 20 years of actual clinical experience in counseling patients about their medications, as well as internationally-recognized expertise in patient education, patient compliance and behavior modification. We know what patients need.
  • We can save you precious DTC advertising dollars by keeping the PPI to one page while still meeting all FDA and patient education requirements.
  • Our expertise in patient information and patient education can add a unique perspective to your DTC strategic planning and help give your product a competitive edge.
Consumer Health Information Corporation has expertise in:
  • Customized Corporate Guidelines for Patient Labeling
  • Development of patient information that meets health literacy and patient comprehension requirements
  • FDA-approved Patient Package Inserts (PPIs)
  • Patient information presented in “patient-friendly” Brief Summaries
  • FDA review process
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Click here for more information about Patient Package Inserts (PPIs)