In 2018, the FDA pledged to improve the drug approval process and the efficiency of drug development, allowing pharmaceutical development consulting firms to serve their clients more effectively. In attempt to prevent drug shortages and to increase generic drug access, the FDA is improving their drug review process. Pharmaceutical development services can be expedited due to the FDA modernizing their approach to clinical trial design.Several processes such as Fast Track, Breakthrough Therapy, Priority Review and Accelerated Review help pharmaceutical development consulting firms reduce the time for project completion. Pharmaceutical companies developing new antibiotics may see a shorter pathway for approval due to the growing prevalence of drug-resistant bacteria. In addition, the FDA is showing a pattern of approving cancer treatments based on a common biomarker across different types of tumors, instead of the location in the body where the tumor originated. It is interesting times for pharmaceutical development consulting firms. Pharmaceutical consultants share with their clients several firsts for the FDA, including marijuana-based drugs approved for rare diseases and non-opioid drug approval for the management of opioid withdrawal symptoms. There are currently a few drugs awaiting FDA approval for cancer, pain management, immune deficiency and rare diseases. Prior to starting a new drug application (NDA), it is important to speak with a pharmaceutical consultant or regulatory affairs professional, in order to classify and select the shortest pathway to market for your product. The actions of the FDA in 2018 has demonstrated the agency’s commitment to make their review processes more efficient, allowing pharmaceutical development consulting firms the opportunity to explore all avenues available for their clients.
Author Information
Christina Sanchez Miller, MPH has over 20 years of management, biologics, quality assurance and research experience in the medical field. She is a published author in scientific books, papers and has presented at several international conferences. Christina has developed medical applications in the biologics field. Her experience includes operations and consulting in FDA Adverse Event Reporting, FDA Product Deviation Reporting, FDA 483’s, cGTP’s, infection control, certified ISO Class 5, 7, 8 development and maintenance, QIC and auditing.
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 pharmaceutical development consulting group focusing on NDA regulatory services, FDA ANDA submissions, and IND consulting 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.
