Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products that improve the quality of life for their patients. However, this often is associated with austere conditions wherein time and funds are both in short supply.
Effective use of Real World Data (RWD) and Real World Evidence (RWE) can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services, expedite a FDA Pre-Submission Review, and lead to FDA Approval.
The term “Real World Data” and “Real World Evidence” can be found in the literature as early as the 1970s.
In a FDA Pre-Submission that leads to FDA Approval, more does not equal better and more does not equal relevance to a specific Pharmaceutical Drug or Biologic Product.
The effective use of RWD and RWE for use in a FDA Pre-Submission requires a clear understanding of how CDER & CBERs define and apply each term.
- “Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.
- Real-World Evidence (RWE) is the clinical evidence about the usage and potential benefits, or risks of a medical product derived from analysis of RWD.”
- “Under FDA’s RWE Program, evidence from traditional clinical trials will not be considered RWE. However, various hybrid or pragmatic trial designs and observational studies could generate RWE.”
Drug Development Services, are the cost effective means to expedite the compilation, documentation, and written description of the integration of safety, effectiveness, and risk rationales and justifications required to use RWD, RWE, and Clinical Trial Protocols for inclusion with your FDA Pre-Submission Communications.
Effective and expediting Drug Development Services, can also include use of a Master Protocols, Centralized Protocols, and/or Decentralized Protocols, as well as Digital Health Technologies.
Effective use of RWD and RWE is most likely to occur under the guidance of trusted FDA Regulatory Consultants who compile, write, submit, and facilitate your FDA Pre-Submission, WROs, Meetings, responses, etc.
Successful FDA Regulatory Consultants, know the vital key FDA Pre-Submission content and manner of communications that most often lead to FDA Approvals, the compliant use and integration of RWD, RWE, and how to identify and document the Protocol content and details you will need.
William E. Spanogle, Ph.D. has over 30 years of management, full spectrum Regulated Life Sciences, RA, QA, EU-MDR, QMS, PMS, CSV/CSA, and R&D experience. He is a published ISPE Invitational author in Pharmaceutical and Biologics Product and Process Development and has presented and trained thousands of professionals on QbD, Design Controls, Science-Risk Based Product Characterization, and Risk Management at several international conferences and numerous private corporate sessions. Dr. Spanogle has taken scores of Regulated Life Science Products from discovery to approval and launch; and audited, identified, and remediated QMS deficiencies.
Pharmaceutical Development Group (PDG) is a global scientific & regulatory consulting firm with extensive experience in the strategic development of drug products, biologics, medical devices, combination products and FDA regulatory affairs. PDG is a Regulated Life Sciences consulting group focusing on IND, ANDA, NDA, Biologics, and Medical Device regulatory services. PDG is a subsidiary of Biotech Research Group Corporation.
The opinions and statements in this blog are those of the authors and do not necessarily reflect those of PDG. This blog is based on personal experience and reviews of information publicly available or identified in other database searches.