Podcast
Questions and Answers
What is the primary legal basis for the exclusive use of a trademark?
What is the primary legal basis for the exclusive use of a trademark?
How does registration of a trademark function in relation to ownership claims?
How does registration of a trademark function in relation to ownership claims?
What distinguishes know-how from trade secrets?
What distinguishes know-how from trade secrets?
What is a primary reason for keeping a trade secret instead of patenting an invention?
What is a primary reason for keeping a trade secret instead of patenting an invention?
Signup and view all the answers
Which of the following statements is true regarding copyrights?
Which of the following statements is true regarding copyrights?
Signup and view all the answers
What is the maximum period allowed for responding to major amendments?
What is the maximum period allowed for responding to major amendments?
Signup and view all the answers
What happens if an applicant fails to respond to minor deficiencies within the stipulated time?
What happens if an applicant fails to respond to minor deficiencies within the stipulated time?
Signup and view all the answers
Which class of drugs is explicitly mentioned as requiring certification?
Which class of drugs is explicitly mentioned as requiring certification?
Signup and view all the answers
What regulatory change did the FDA make in 1982 concerning antibiotics?
What regulatory change did the FDA make in 1982 concerning antibiotics?
Signup and view all the answers
Which of the following is not considered an aspect of intellectual and industrial property?
Which of the following is not considered an aspect of intellectual and industrial property?
Signup and view all the answers
What distinguishes a trademark from a patent?
What distinguishes a trademark from a patent?
Signup and view all the answers
What must an application for drug certification be submitted to?
What must an application for drug certification be submitted to?
Signup and view all the answers
What is the primary aim of the FDA's batch testing for drugs?
What is the primary aim of the FDA's batch testing for drugs?
Signup and view all the answers
What is the main role of the project manager in the FDA application review process?
What is the main role of the project manager in the FDA application review process?
Signup and view all the answers
What happens if an application is found to be incomplete during the initial review?
What happens if an application is found to be incomplete during the initial review?
Signup and view all the answers
Which type of drug application is categorized as a high-priority review?
Which type of drug application is categorized as a high-priority review?
Signup and view all the answers
How long does the FDA have to issue an action letter after sending an 'Acceptance to file' letter?
How long does the FDA have to issue an action letter after sending an 'Acceptance to file' letter?
Signup and view all the answers
What is included in the 'Not Approvable' letter issued by the FDA?
What is included in the 'Not Approvable' letter issued by the FDA?
Signup and view all the answers
Within how many days must the FDA check the completeness of content in an application?
Within how many days must the FDA check the completeness of content in an application?
Signup and view all the answers
Which of the following statements about ANDAs is correct?
Which of the following statements about ANDAs is correct?
Signup and view all the answers
During the review process, how often can meetings be held between the applicant and the FDA?
During the review process, how often can meetings be held between the applicant and the FDA?
Signup and view all the answers
Study Notes
FDA Review Procedures
- Applications (NDA, BLA, ANDA) submitted to FDA for review are sent to the relevant Center for Review.
- FDA charges application fees for NDA and BLA, but not for ANDA.
- After receiving an application, the Center assigns a project manager to coordinate the review.
- The project manager is the primary contact for the applicant.
Review Cycle Phases
- Applications are initially reviewed for completeness and technical details in the document control center within 60 days of receipt.
- If complete, an "Acceptance to File" letter is sent.
- If incomplete, a "Refuse to File (RTF)" letter is sent; the applicant needs to provide missing information.
Review Priorities
- FDA initiates a review after receiving complete documents.
- Documents are distributed to review team members.
- Applications are prioritized based on type (standard or priority).
- AIDS drug applications are high-priority.
- A 90-day meeting is an option for applicant-FDA discussion during the review cycle.
Issuance of Action Letters
- The FDA (project manager) issues an action letter within 180 days of the "Acceptance to file" letter.
- The letter shows the results of the technical evaluation by different FDA offices.
- An "Approval Letter" is issued if the application is completely acceptable.
- A "Not Approvable Letter" (major problems) means the application cannot be approved;
- An "approvable letter" (minor problems) signifies the application can be approved upon addressing deficiencies.
- Deficiencies are highlighted.
- Corrective actions are described.
Amendments
- Telephonic amendments require responses within 10 working days.
- Minor amendments necessitate responses within 60 working days of receiving the deficiency letter.
- Major amendments require responses within 180 working days of receiving the deficiency letter.
Application Review Suspension
- Review stops while responding to minor or major deficiencies.
- If minor deficiencies are not resolved within 60 days, the category changes to a major amendment.
- Telephonic amendments do not stop the review process.
Certification of Drugs
- Insulin and antibiotics are typically certified drugs.
- Certain antibiotics may be exempt from certification.
- FDA regulations mandate that each drug batch meets quality, strength, etc., standards.
- Application for certification is submitted to the Commissioner.
- In 1982, a regulation exempted most antibiotics from batch certification.
Batch Confirmation of Antibiotics
- For 20 years, batch assay results and samples were mandatory for approved antibiotics.
- Batch-to-batch integrity and uniformity were the testing goals.
- The procedure was costly and time-consuming.
- The FDA discontinued the practice due to its ineffectiveness.
- Batch certification remains for insulin products.
Intellectual Property
- Intellectual and industrial property includes patents, trademarks, copyrights, trade secrets, and know-how.
Patents
- A patent is a temporary monopoly granted to inventors, allowing them to prevent others from making, using, or selling the invention.
- The patent's validity must be upheld for the right to be absolute.
Trademarks
- A trademark's value and validity are not derived from static laws.
- The right to use a trademark depends on proper use by the owner.
- Registration serves as notice of claim and use.
Copyrights
- Copyright is a legal right granted to creators of artistic and literary works to enjoy their intellectual labor for a specific period, without fearing plagiarism or copying.
Know-How
- Know-how refers to the combined knowledge of individuals or companies (often in manufacturing processes).
- It is closely held and typically not easily translated into patents.
Trade Secrets
- Trade secrets are specific bits of knowledge or ingenuity that are not patented or disclosed publicly.
- Their protection ensures exclusive use by the holder.
- The length of a trade secret's protection has a theoretically infinite lifespan compared to the 17 years, or less, patent protection.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
Related Documents
Description
Explore the review processes for FDA applications such as NDA, BLA, and ANDA. This quiz covers the stages of application review, the roles of project managers, and how applications are prioritized. Test your knowledge on the steps and requirements involved in FDA reviews.
