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eCTD 4.0: New Standard for FDA Submissions [APAC Webinar]

The world of electronic regulatory submissions is about to change with the introduction of eCTD (Electronic Common Technical Document) v4.0. This latest version of the standard includes updated specifications and guidelines for the preparation and submission of electronic regulatory documents. During this webinar, we will cover the similarities and differences between the FDA’s eCTD v4.0 … Continued

https://www.certara.com/webinar/ectd-4-0-new-standard-for-fda-submissions-apac-webinar/

Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates

In recent years, oncology drug developers have invested in antibody-drug conjugates (ADCs). These targeted therapies deliver cytotoxic small-molecule drug payloads to cancer cells. The cytotoxic payload attaches to a monoclonal antibody (designed for binding to the target) through a linker. Having a solid clinical pharmacology strategy is essential to successfully developing these therapies. The US … Continued

https://www.certara.com/blog/reflections-on-the-new-fda-clinical-pharmacology-guidance-for-antibody-drug-conjugates/

FDA SEND Dataset Requirements for Nonclinical Studies

https://www.certara.com/white-paper/fda-send-dataset-requirements-for-nonclinical-studies/

SEND Dataset Services for FDA IND Submissions

Cleansing, mapping, programming and QC of in-scope nonclinical study data are all critical pieces of the regulatory submission process for both FDA Investigational New Drug (IND) Applications and New Drug Applications (NDAs). Certara’s expert biostats programmers provide submission ready CDISC SEND datasets and supporting documentation; these services are often utilized by biopharma companies without dedicated … Continued

https://www.certara.com/services/send-dataset-services-for-fda-ind-submissions/

Dual Filing Strategies: How to Jointly Publish Marketing Applications for EMA and FDA

Even if the product is the same, the applications for marketing authorization in Europe and the United States can look very different. This presentation will explore the major differences between EMA marketing applications (MAAs) and U.S. FDA marketing applications (NDAs/BLAs), strategies for publishing in tandem, and even means to “clone” sections for efficiency. Tips for … Continued

https://www.certara.com/on-demand-webinar/dual-filing-strategies-how-to-jointly-publish-marketing-applications-for-ema-and-fda/

The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA

https://www.certara.com/publication/the-role-of-model-master-files-for-sharing-acceptance-and-communication-with-fda/

How to Navigate the FDA Landscape for an Orphan Drug

Rare diseases are a public health priority. FDA has launched several programs and a final guidance to address the unmet need for orphan drugs.

https://www.certara.com/blog/how-to-navigate-the-fda-landscape-for-an-orphan-drug/

Thank You – Attain FDA Label Claims for Kinase Inhibitor Drugs with Simcyp – brochure

How about a free demo of the Simcyp™ PBPK Simulator? Complete the form to book your no-obligation demo of the standard software for Population-based Physiologically Based Modeling and Simulation… and see how better off you could be with Simcyp!

https://www.certara.com/thank-you-attain-fda-label-claims-for-kinase-inhibitor-drugs-with-simcyp-brochure/

Attain FDA Label Claims for Kinase Inhibitor Drugs with the Simcyp™ Simulator without the need to run clinical studies

The Simcyp™ Simulator has been used by large pharma and innovative biotech companies to inform, reduce and/or replace clinical studies for 40 Kinase Inhibitor (KI) drugs in the past decade. This 20+ year in silico technology has been accepted by global regulators, not just in oncology, but also inflammatory, rare, neurology and other diseases. While best known for … Continued

https://www.certara.com/attain-fda-label-claims-for-kinase-inhibitor-drugs-with-the-simcyp-simulator-without-the-need-to-run-clinical-studies/

Key Lessons from the 2nd Annual FDA ASCO WORKSHOP on Getting the Dosage Right: Optimizing Dosage Selection Strategies in Combination Cancer Therapies

Cancer treatment has evolved from generally cytotoxic therapies towards drugs that target specific pathways and alterations in cancer cells. Patients tolerate targeted therapies better, and their treatment continues over a period of years, instead of a few weeks. These improvements in cancer treatment spurred the FDA’s Project Optimus initiative which has altered the criteria used … Continued

https://www.certara.com/blog/key-lessons-from-the-2nd-annual-fda-asco-workshop-on-getting-the-dosage-right-optimizing-dosage-selection-strategies-in-combination-cancer-therapies/

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