On the industry side, the sponsor needs to establish the standard operating procedures (SOP) and the working procedure documents (WPDs) to ensure the compliance of the regulatory guidance and GCP and to improve the efficiency. On the regulatory side, it is important to establish the good review practice to ensure that the same standard procedures are following during the review process for drug approval.
These good review practices could cover the review process in different areas: efficacy, safety, pregnancy, CMC,... They are supposed to be written for FDA reviewers, however, understanding the good review practice is also very helpful for sponsor to prepare the regulatory submission documents in a way that is amenable to the reviewers. The mis-communication between the sponsor and the regulatory could be minimized. All necessary information/analyses required per good review practice are included in the submission documents.
Below are some links related to good review practice:
- Good Review Practices (GRPs)
- Biostatistics New Drug Application Review Template
- Biostatistics Biological Product Application Review Template
- Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review
- Review Guidance: Evaluation of Human Pregnancy Outcome Data
- Reviewer Guidance: Evaluating the Risks of Drug Exposure in Human Pregnancies
- Safety Review and eCTD
- Guidance for Reviewers Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs)