Preparing Clinical Sections of NDABLA

The knowledge and skill needed to prepare an NDA/BLA/PLA includes the ability to:

• Verify individual study tabulations against overall summary computer listings.

• Prepare brief descriptions of the studies.

• Interpret critical clinical safety and efficacy results.

• Interpret laboratory findings.

• Develop clear tables and figures to illustrate and support clinical findings.

• Summarize, interpret, and integrate the overall safety and efficacy results.

• Prepare NDA/BLA clinical study summaries, benefit-risk summary, expert reports, and package insert.

In addition, an understanding of electronic NDA/ BLAs (CANDA/BLAs) and EU/FDA data presentation requirements are useful.

The expert report usually generates considerable discussion within a project. The document is most often prepared by sponsor under the guidance of an external expert. Whilst internal experts are acceptable, it should be remembered that the regulatory authorities are looking for an individual who knows the drug thoroughly and can express an unbiased opinion of its medical importance. The expert report is not just a summary but a critical assessment of the clinical evaluation of the drug.

The expert report provides an independent assessment of the risk-benefit of the drug and its use. The text is limited to 25 pages, but may include an 'unlimited' number of attachments. Many companies have been creative in font size and two-sided preparation of the document.

Certain trends and directions can be recognized in the preparation of NDA/BLAs. The ICH has the long-term goal of harmonizing the content of European, US and Japanese NDA/BLAs. EU registration dossiers are becoming more detailed in the process and are expected to include integrated summaries in the future. The US FDA will accept more non-US data for drug approval as common high standards for clinical trials become well established in the world. Finally, electronic NDA/BLAs will be the norm and are already required in the USA.

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