FDA Review Procedures Overview

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.