What you need to know about the FDA’s proposed new PMR/PMC forms In October 2020, FDA released a draft guidance indicating that they will be encouraging the use of new forms FDA 3988 and FDA 3989 to improve the agency’s collection, identification, and use of information regarding PMRs (post marketing requirements) and PMCs (post marketing commitments). The … Continued
FDA holds more than 400 SimcypTM and PhoenixTM software licenses across 12 divisions and offices PRINCETON, N.J.— 2021年12月21日 – Certara, Inc. バイオシミュレーションのグローバルリーダーであるサターラ（Nasdaq：CERT), a global leader in biosimulation, today announced that the U.S. Food and Drug Administration (FDA) has renewed and expanded its licenses of Certara’s proprietary biosimulation software, with more than 400 … Continued
My previous blog on COVID-19 vaccines as of 2021年10月11日 clarified and discussed the differences in terms and definitions for Emergency Use Authorization (EUA) and “full” FDA approval and presented a table of EUA and approved COVID-19 vaccines in the United States. Since October 11, there have been numerous additions to the EUAs including … Continued
Accelerate your FDA review process with a rolling NDA/BLA eCTD submission with Certara’s GlobalSubmit eCTD software and eCTD publishing specialists
By Carrie Mitchell and Jason Buck Recently, the FDA issued a guidance concerning the penalties for noncompliance with ClinicalTrials.gov requirements. Sponsors conducting clinical trials should understand and follow the requirements for registering trials and reporting the results on ClinicalTrials.gov. The requirements have been in force since 2007 and were part of Section 801 of the … Continued
Modeling and simulation were used to optimize a sponsor’s Phase 3 clinical trial study design to achieve efficacy and safety goals as well as regulatory approval.
Clarus Therapeutics received FDA approval for an oral testosterone (T) replacement drug. This webinar will review how Phoenix NLME, population PK/PD M&S tool, and Trial Simulator supported this approval.
PRINCETON, NJ – Jan. 23, 2020 – Certara today reported that more than 90% of novel new drug approvals by the US Food and Drug Administration (FDA) in 2019 were supported by Certara software or services.
The U.S. Food and Drug Administration (FDA) recently announced two exciting and innovative initiatives from FDA’s Oncology Center of Excellence: Project Orbis and Real-Time Oncology Review (RTOR) Pilot Program. Project Orbis Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), will provide a framework for concurrent submission and review of oncology products between international … Continued
Final Guidance and Implementation Date The U.S. Food and Drug Administration (FDA) has released long-anticipated final guidance with the implementation date for all promotional materials submissions via electronic common technical document (eCTD) format. The guidance titled, “Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs” defines … Continued