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This document provides a regulatory summary and action recommendation for Hizentra™, an immune globulin subcutaneous product indicated for the treatment of primary immune deficiency.

How to fill out summary basis for regulatory

How to fill out Summary Basis for Regulatory Action

1. Gather all relevant data related to the application.
2. Summarize the key points of the application and the underlying science.
3. Outline the evaluation of the submitted data, including any clinical studies.
4. Detail the safety and efficacy of the product based on the gathered evidence.
5. Include significant findings, recommendations, and any post-market obligations.
6. Ensure the document is clear, concise, and follows the regulatory agency's guidelines.

Who needs Summary Basis for Regulatory Action?

1. Pharmaceutical companies seeking approval for new drugs.
2. Regulatory agencies reviewing drug applications.
3. Healthcare professionals needing insights on new treatments.
4. Research organizations evaluating product safety and efficacy.

People Also Ask about

What is NDA and Anda in Pharma?

Discovery and. Development. Discovery and Development. Preclinical Research. Preclinical Research. Drugs undergo laboratory and animal testing to answer basic questions about safety. Clinical Research. Clinical Research. FDA Review. FDA Review. FDA Post-Market. Safety Monitoring.

What is FDA regulatory approval?

If the FDA team determines that the research, data, and evidence shows that the drug is safe and effective for the intended use, the FDA approves the drug.

What is the summary basis of approval?

For many newly approved drugs, CDB prepares a Summary Basis of Approval (SBA). Purpose: To evaluate and approve new drugs for marketing on the basis of safety and effectiveness (efficacy), to assure that these drugs are properly labeled, and to share with the public the key facts on which approval is based.

What is a summary basis of approval?

SBAs are prepared when the drug is released for use in the practice of medicine. Properties: Safety, efficacy, effectiveness. Selection process: The CDB has criteria that determine which drugs justify an SBA. No one can request that an assessment be done beyond the intended target group of a given drug.

What is the summary basis of decision?

Summary Basis of Decision (SBD) for Health Canada's Summary Basis of Decision (SBD) documents outline the scientific and regulatory considerations that factor into Health Canada regulatory decisions related to drugs and medical devices.

What is the difference between NME and NCE?

An NME is a drug whose active ingredient contains no active moiety that has been previously approved by the FDA, while an NCE is a drug that does not contain an active moiety previously approved by the FDA. With the near word-for-word similarities between these two classifications, they can appear to be duplicative.

What are the four phases of drug approval?

Four phases of drug development. Drug development can be divided into four phases: discovery, preclinical studies, clinical development and market approval. The image below provides an overview of the process, including an estimated timeline for each step.

What are the regulatory functions of the FDA?

FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. FDA also has the responsibility in maintaining the safety of our nation's food supply (human and animal), cosmetics, and products that emit radiation.

For pdfFiller’s FAQs

What is Summary Basis for Regulatory Action?

The Summary Basis for Regulatory Action (SBRA) is a document prepared by regulatory agencies, such as the FDA, that provides a summary of the scientific and regulatory rationale for a specific regulatory decision, including approvals or other actions taken on pharmaceutical products.

Who is required to file Summary Basis for Regulatory Action?

Filing a Summary Basis for Regulatory Action is typically the responsibility of the sponsor or manufacturer who submits a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) to the regulatory agency.

How to fill out Summary Basis for Regulatory Action?

To fill out an SBRA, the sponsor must provide detailed information about the drug, including its indications, dosing, pharmacology, clinical trial data, risk-benefit analysis, and regulatory history, in a structured format as specified by the regulatory guidelines.

What is the purpose of Summary Basis for Regulatory Action?

The purpose of the SBRA is to document the rationale behind regulatory decisions, ensuring transparency and providing a reference for future regulatory actions, assessments, and for the public regarding the safety and efficacy of the product.

What information must be reported on Summary Basis for Regulatory Action?

The SBRA must report information including the product's name, its proposed use, details from clinical studies, potential risks identified, the basis for approval or action taken, and any conditions or recommendations from the regulatory agency.