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How to improve your chances of getting FDA approval
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- The Real-Time Oncology Review (RTOR) Pilot Program for New Molecular Entities Approvals
- FDA Guidance for Human Gene Therapy for Hemophilia A & B
- Patient Centricity in Clinical Trials
- How to improve your chances of getting FDA approval
- Biomarker Applications in Drug Discovery and Development
- Risk-based monitoring in clinical research
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How to improve your chances of getting FDA approval
[/vc_column_text][vc_column_text]After completing all phases of a clinical trial, the FDA will review the findings and hold an open discussion — often virtually — in which pharmaceutical companies will present evidence that their proposed drug is effective and offers significant advantages over existing drugs for the same disease. The objective here isn’t to prove that the new medicine is safe — that has already been shown through in vitro and in vivo research — but to show that it will dramatically enhance patients’ lives.
Medicine has been transformed by recombinant DNA technology. From the 1980s through the first part of the decade, FDA approvals’ total and relative rate for recombinant proteins increased. Despite significant growth in recombinant protein-based therapy, the rate of new biologics approvals may have plateaued. In terms of the types of biopharmaceuticals, indications targeted, and the molecular basis of therapeutic action, biologics is a complicated subject that has been dynamic.
Investors and boards of directors should direct management to guarantee that the best data management and manufacturing practices are followed. They may take a few simple actions to increase their prospects of regulatory clearance and optimise their exit worth in the future. Data management, safety and clinical milestones, and data management are all part of these programmes.
- Implement a digital data platform early in the product life cycle. A stage that acts as a single source of data truth for development, batch, specifications, and limitations data and enables quick analytics would bring concrete business advantages while reducing corporate risks.
- Secure full data transparency in supply and quality agreements with contract manufacturers.While experts are skilled at creating wording to handle indemnification and choice of law, these agreements must be carefully negotiated since they control intellectual property, drug product quality, data integrity, and FDA compliance.
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References
Kinch, Michael S. “An overview of FDA-approved biologics medicines.” Drug discovery today 20.4 (2015): 393-398.[/vc_column_text][/vc_column][/vc_row]
