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FDA Trends for Accelerated Drug Approvals in Oncology Indications

The FDA has modified and increased expectations around data needed to support accelerated approvals in oncology Unlike prior trends, randomized controlled trials will be the preferred approach to support an application for accelerated approval moving forward the acceptability of single arm trials for accelerated approval will receive significant scrutiny Prolonged duration on the market for … Continued

https://www.certara.com/poster/fda-trends-for-accelerated-drug-approvals-in-oncology-indications/

FDA Draft Guidance on Planned PMR/PMC Forms 3988 & 3989

What you need to know about the FDA’s proposed new PMR/PMC forms In October 2020, FDA released a draft guidance indicating that they will be encouraging the use of new forms FDA 3988 and FDA 3989 to improve the agency’s collection, identification, and use of information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

https://www.certara.com/blog/fda-provides-draft-guidance-on-planned-pmr-pmc-forms-3988-3989/

Certara Simcyp™ Group Awarded Two New Grants from US FDA

Programs focus on use of physiologically-based pharmacokinetic (PBPK) modeling for demonstrating virtual bioequivalence and predicting drug absorption of topical formulations PRINCETON, N.J.— August 29, 2023– Certara (Nasdaq: CERT), a global leader in biosimulation, today announced that the Simcyp group has been awarded two new grants from the U.S. Food and Drug Administration (FDA) to expand its … Continued

https://www.certara.com/pressrelease/certara-simcyp-group-awarded-two-new-grants-from-us-fda/

Certara collaborates with Korea Institute of Toxicology to ensure FDA submission-ready SEND dataset

Software will aid optimizing pre-clinical data management in accordance with global standards and guidelines. Seoul, SOUTH KOREA August 4rd –  Certara, Inc. (Nasdaq: CERT), a global leader in Biosimulation, today announced that a Korea Institute of Toxicology (KIT) have decided to implement Certara’s Pinnacle 21 Enterprise data conformance and submission software and SEND Explorer pre-clinical … Continued

https://www.certara.com/announcement/certara-collaborates-with-korea-institute-of-toxicology-to-ensure-fda-submission-ready-send-dataset/

AAPS eChalk talk: FDA Modernization Act – What Does it Mean for Pharmaceutical Scientists? 

Historically, the FDA has required drug discovery and development programs to include animal testing. With the 2022 passage of the FDA Modernization Act 2.0, the definition of “nonclinical tests” conducted to support pharmaceutical development has been broadened to include adjunct and complementary testing methods. In this webinar with Certara’s Dr. Jim Herman, he will discuss how scientists can use innovative, … Continued

https://www.certara.com/on-demand-webinar/aaps-echalk-talk-fda-modernization-act-what-does-it-mean-for-pharmaceutical-scientists/

FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug Developers

2023 guidance from FDA on dosages in oncology provides further context on expectations with Project Optimus. Reprinted with permission from Applied Clinical Trials. Applied Clinical Trials is a copyrighted publication of MultiMedia Healthcare, LLC. All rights reserved.

https://www.certara.com/article/fdas-project-optimus-guidance-highlights-and-tips-for-success-for-oncology-drug-developers/

Certara Customers Received 90 Percent of US FDA Novel Drug Approvals for 9th Consecutive Year

Asserts Certara’s leadership in advancing the development and approval of new drugs for patients PRINCETON, N.J.— April 27, 2023 – Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that 90 percent of new drug approvals by the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Review (CDER) were received … Continued

https://www.certara.com/pressrelease/certara-customers-received-90-percent-of-us-fda-novel-drug-approvals-for-9th-consecutive-year/

What you should know about FDA Project Optimus for your oncology drug approval

Historically, the dosing strategy for oncology drugs has focused on the maximum tolerated dose. This has resulted in drugs’ pharmacokinetic (PK) profiles, pharmacokinetic/pharmacodynamic (PK/PD) relationships, and clinical target inhibition largely being ignored. Thus, cancer patients often struggle to tolerate their medication doses long-term, requiring dose modifications including dose reductions and holidays. What’s more, for many … Continued

https://www.certara.com/on-demand-webinar/what-you-should-know-about-fda-project-optimus-for-your-oncology-drug-approval/
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