Portfolio and project planning and management in the drug discovery, evaluation, development, and regulatory review process

Abstract Mass spectrometry–based in vitro diagnostic devices that measure proteins and peptides are underutilized in clinical practice, and none has been cleared or approved by the Food and Drug Administration (FDA) for marketing or for use in clinical trials. One way to increase their utilization is through enhanced interactions between the FDA and the clinical mass spectrometry community to improve the validation and regulatory review of these devices. As a reference point from which to develop these interactions, this article surveys the FDA's regulation of mass spectrometry–based devices, explains how the FDA uses guidance documents and standards in the review process, and describes the FDA's previous outreach to stakeholders. Here we also discuss how further communication and collaboration with the clinical mass spectrometry communities can identify opportunities for the FDA to provide help in the development of mass spectrometry–based devices and enhance their entry into the clinic.

Download Full-text

A Baseline Analysis of Regulatory Review Timelines for ANVISA: 2013–2016

Therapeutic Innovation & Regulatory Science ◽

10.1007/s43441-020-00169-5 ◽

2020 ◽

Vol 54 (6) ◽

pp. 1428-1435

Author(s):

Prisha Patel ◽

Daniela Marreco Cerqueira ◽

Gustavo Mendes Lima Santos ◽

Renata de Lima Soares ◽

Varley Dias Sousa ◽

...

Keyword(s):

Performance Improvement ◽

Review Process ◽

Response Times ◽

Regulatory Agencies ◽

Regulatory Review ◽

Performance Targets ◽

Approval Time ◽

Timely Access ◽

Data Points ◽

Regulatory Assessment

Abstract Background The Brazilian health regulatory agency (Agência Nacional de Vigilância Sanitária, ANVISA) has embarked on transformational initiatives to fulfill its mandate to provide timely access to safe, effective, and quality therapeutics. A new Brazilian law was enacted to provide the agency with greater flexibility. Optimizing Efficiencies in Regulatory Agencies (OpERA) is a regulatory-strengthening program that seeks to provide benchmarking data that can be used to define performance targets and focus performance improvement. The objective of this study was to use OpERA methodology to undertake a retrospective analysis of the timelines associated with important components of the ANVISA regulatory review process to establish a baseline against which the influence of the new law could be measured. Methods The OpERA tool was used to collect specific milestone data that identify time periods, review stages, and data points for products approved by ANVISA 2013–2016. Results For the 138 products approved in this cohort, the overall median approval time was 795 days. ANVISA and submitting companies will need to reduce their review and response times by approximately half in order to meet the total time goal of 365 days. Conclusions The observations from this baseline study have identified opportunities for ANVISA and sponsor companies to collaborate to reduce regulatory assessment times while assuring the timely approval of safe and effective, quality medicines. These analyses will be repeated to determine how the provisions of the new Law will impact the activities of ANVISA and the extent of sponsors' contributions to this effort.

Download Full-text