Get the free The Pediatric Exclusivity Provision Status Report to Congress

This document is a status report submitted by the Department of Health and Human Services to Congress regarding the Pediatric Exclusivity Provision, established by the Food and Drug Administration

How to fill out form pediatric exclusivity provision

How to fill out The Pediatric Exclusivity Provision Status Report to Congress

1. Begin by obtaining the official Pediatric Exclusivity Provision Status Report template from the appropriate agency.
2. Enter the title of the report at the top of the document.
3. Fill in the date of submission in the designated field.
4. Provide information about the manufacturer including name, address, and contact information.
5. List all relevant products that are being reported on, along with their approval dates.
6. Include data on any pediatric studies that have been conducted, highlighting their findings.
7. Summarize the impact of the products on pediatric health outcomes.
8. Ensure all data is accurate and supported by relevant documentation.
9. Review the completed report for any errors or omissions.
10. Submit the report by the specified deadline to the designated congressional committee.

Who needs The Pediatric Exclusivity Provision Status Report to Congress?

1. Pharmaceutical manufacturers who have received pediatric exclusivity.
2. Congressional committees responsible for health and drugs.
3. Regulatory agencies overseeing pediatric drug development.
4. Patients and advocacy groups focused on pediatric health.

People Also Ask about

What is pediatric exclusivity?

Exclusivity is granted to a new drug applicant if statutory requirements are met. In case of pediatric exclusivity, a 6-month period of exclusivity is added to all existing patents and exclusivity on all applications held by the sponsor for that active moiety.

Can the six months of pediatric exclusivity be added to the 5 or 3 years of new drug product exclusivity?

15. Can the six months of pediatric exclusivity be added to the 5 or 3 years of new drug product exclusivity? Yes, pediatric exclusivity is the only exclusivity that runs from the end of other exclusivity protection (New Drug Product and Orphan Drug) or patent protection.

How to qualify for pediatric exclusivity?

How to Qualify for FDA Pediatric Exclusivity Obtain a Written Request containing a detailed description of the studies and the time frame needed for completion. Submit study reports (typically in the form of a new drug application, as a supplement to an approved application, or as an amendment to a pending application).

What is the completion rate and reporting of mandatory pediatric postmarketing studies under the US Pediatric Research Equity Act?

Only 33.8% of mandatory pediatric postmarketing studies have been completed after a median follow-up of 6.8 years, and most drug labels do not include information important for pediatric use. To improve evidence-based prescribing of medicines to children, more timely completion of pediatric drug studies is needed.

Does pediatric exclusivity attach to orphan drug exclusivity?

Pediatric exclusivity attaches to the END of all existing marketing exclusivity and patent periods. Waxman-Hatch exclusivity, orphan exclusivity, and patent periods run concurrently.

How does pediatric exclusivity work?

For drug products approved under the FD&C Act, pediatric exclusivity adds six months to the expiration of the patent to determine the earliest date of expiration of a court-ordered permanent injunction preventing the infringement of a patent by a proposed ANDA or 505(b)(2) product.

What is the exclusivity of orphan drugs?

The term “minus 1” indicates that the NCE is only one small change away from an already FDA-approved and marketed drug. The approval process of an NCE minus 1 filing is usually quicker and less expensive than entirely new drugs, because the FDA may make use of efficacy and safety data available from the original drug.

For pdfFiller’s FAQs

What is The Pediatric Exclusivity Provision Status Report to Congress?

The Pediatric Exclusivity Provision Status Report to Congress is a report that outlines the status and effectiveness of the Pediatric Exclusivity Provision, which encourages pharmaceutical companies to conduct clinical studies in children by granting a six-month extension of market exclusivity for approved drugs.

Who is required to file The Pediatric Exclusivity Provision Status Report to Congress?

The report is typically required to be filed by the Food and Drug Administration (FDA) in collaboration with drug manufacturers who receive pediatric exclusivity extensions.

How to fill out The Pediatric Exclusivity Provision Status Report to Congress?

To fill out the report, submitters must gather relevant data on pediatric studies conducted, include details such as the drug's name, study outcomes, and the impact of these studies on labeling changes or market exclusivity extensions.

What is the purpose of The Pediatric Exclusivity Provision Status Report to Congress?

The purpose of the report is to provide Congress with a transparent overview of the pediatric studies incentivized by the exclusivity provision, assess the provision's effectiveness, and ensure that children's health needs are being addressed.

What information must be reported on The Pediatric Exclusivity Provision Status Report to Congress?

The report must include information such as the number of drugs granted exclusivity, the results of pediatric studies, any changes in drug labeling for pediatric use, and an assessment of how these studies have affected pediatric healthcare.