Get the free Notice of Regulatory Review Period Determination for FLECTOR - gpo

This document provides notice of the FDA's determination of the regulatory review period for the human drug product FLECTOR, relevant for patent extension applications.

How to fill out notice of regulatory review

How to fill out Notice of Regulatory Review Period Determination for FLECTOR

1. Begin by obtaining the official Notice of Regulatory Review Period Determination document for FLECTOR.
2. Read the instructions provided in the document carefully.
3. Fill in the required fields, including your name, date, and any relevant identification numbers.
4. Provide specific details regarding the regulatory review period for FLECTOR, ensuring accuracy.
5. Include any necessary supporting documentation as required.
6. Review the completed form for any errors or omissions before submission.
7. Submit the Notice to the appropriate regulatory body as instructed in the guidelines.

Who needs Notice of Regulatory Review Period Determination for FLECTOR?

1. Healthcare providers who prescribe FLECTOR.
2. Pharmaceutical companies involved in the production or distribution of FLECTOR.
3. Regulatory officials or agencies overseeing the approval of FLECTOR.
4. Patients seeking to understand regulatory details related to FLECTOR.

People Also Ask about

What is the maximum PTE patent?

154 to provide that the term of a patent (other than a design patent) begins on the date the patent issues and ends on the date that is twenty years from the date on which the application for the patent was filed in the United States or, if the application contains a specific reference to an earlier filed application

How is PTE patent calculated?

• PTE is the sum of the “testing period” and the “approval period,” less: ◊ The number of days which were on or before the patent issued. ◊ The number of days during which the applicant did not act with due diligence. ◊ One-half the number of days of the testing period after the patent issued.

How is patent value calculated?

Market method: Market-based methods value patents through comparison with prices achieved in recent comparable transactions. These methods require an active market, a comparable exchange of IP between two independent parties, and sufficient access to transaction price information.

What is the difference between PTA and PTE patents?

Using the issue date of the original patent meant the entire regulatory review period occurred after the patent was issued, so the patent was awarded a maximum PTE award of five years.

What is the regulatory review period?

A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins.

For pdfFiller’s FAQs

What is Notice of Regulatory Review Period Determination for FLECTOR?

The Notice of Regulatory Review Period Determination for FLECTOR is a formal communication that specifies the duration of the regulatory review period for the medication FLECTOR, which is necessary for determining patent exclusivity.

Who is required to file Notice of Regulatory Review Period Determination for FLECTOR?

The sponsor or manufacturer of FLECTOR, typically the entity that holds the new drug application (NDA) or abbreviated new drug application (ANDA), is required to file the Notice of Regulatory Review Period Determination.

How to fill out Notice of Regulatory Review Period Determination for FLECTOR?

To fill out the Notice of Regulatory Review Period Determination for FLECTOR, the applicant must complete the specified form with details about the drug's approval date, patent information, and any relevant data regarding the review period as mandated by regulatory guidelines.

What is the purpose of Notice of Regulatory Review Period Determination for FLECTOR?

The purpose of the Notice of Regulatory Review Period Determination for FLECTOR is to formally establish and communicate the duration of the regulatory review period, which can affect the timing of generic drug applications and patent protection.

What information must be reported on Notice of Regulatory Review Period Determination for FLECTOR?

The information that must be reported includes the drug's approval date, patent expiration dates, any exclusivity periods granted, and details regarding the review process leading to the determination.