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This document provides a notice regarding the regulatory review period determined by the FDA for the Progel Pleural Air Leak Sealant, including details on the petition process for patent extension.

How to fill out determination of regulatory review

How to fill out Determination of Regulatory Review Period for Purposes of Patent Extension; Progel Pleural Air Leak Sealant

1. Obtain and review the original NDA approval documents for Progel Pleural Air Leak Sealant.
2. Identify the date when the product was first commercially marketed.
3. Compile information regarding any supplements or amendments submitted to the FDA for the product.
4. Calculate the total duration of the regulatory review period by considering the time taken for the NDA review and any relevant extensions.
5. Complete the Determination of Regulatory Review Period form by filling in the identified dates and duration.
6. Submit the completed form to the appropriate patent office along with any required fees.

Who needs Determination of Regulatory Review Period for Purposes of Patent Extension; Progel Pleural Air Leak Sealant?

1. Patent holders of Progel Pleural Air Leak Sealant.
2. Pharmaceutical companies looking to extend patent protection for the product.
3. Legal advisors or patent attorneys involved in patent extension applications.
4. Regulatory affairs professionals in charge of compliance with FDA regulations.

For pdfFiller’s FAQs

What is Determination of Regulatory Review Period for Purposes of Patent Extension; Progel Pleural Air Leak Sealant?

The Determination of Regulatory Review Period for Purposes of Patent Extension for Progel Pleural Air Leak Sealant is a formal assessment by the U.S. Patent and Trademark Office (USPTO) that identifies the time period during which the product was reviewed by the regulatory authority before it received approval. This period is significant for patent holders as it can influence the duration of patent protection afforded to the product.

Who is required to file Determination of Regulatory Review Period for Purposes of Patent Extension; Progel Pleural Air Leak Sealant?

The applicant or holder of the patent for the Progel Pleural Air Leak Sealant is required to file the Determination of Regulatory Review Period. This can include the original patent owner, a licensee, or an assignee who has the rights to seek a patent extension based on the regulatory review period.

How to fill out Determination of Regulatory Review Period for Purposes of Patent Extension; Progel Pleural Air Leak Sealant?

To fill out the Determination of Regulatory Review Period, the applicant must complete the required forms provided by the USPTO, providing relevant information such as the patent number, regulatory review timelines, and details about the approval process of the Progel Pleural Air Leak Sealant. It's essential to ensure all fields are accurately completed and accompanied by necessary documentation.

What is the purpose of Determination of Regulatory Review Period for Purposes of Patent Extension; Progel Pleural Air Leak Sealant?

The purpose of the Determination of Regulatory Review Period is to officially document the duration of regulatory review for the Progel Pleural Air Leak Sealant to determine eligibility for patent extension. This enables the patent holder to potentially extend their patent protection, allowing them to maintain exclusivity in the market for a longer period.

What information must be reported on Determination of Regulatory Review Period for Purposes of Patent Extension; Progel Pleural Air Leak Sealant?

The information that must be reported typically includes the patent number, the dates of the regulatory review process, the approval date for the product, and any relevant correspondence with the regulatory authority. Additional supporting documents may also be required to substantiate the reported timeline.