Certara’s Dr. Fran Brown, Senior Vice President of Drug Development Science, is quoted in this BioSpace article about the FDA’s Complete Response Letter for the Lykos Therapeutics’s MDMA therapy for…
Sponsor companies are now expected to submit globally as quickly as possible. Successful achievement of this combination of speed and complexity requires extensive regulatory knowledge and planning. The first half…
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…
Pinnacle 21 by Certara announces the latest Validation Engines for submissions to Japan PMDA, US FDA, and China NMPA!
This white paper is a step-by-step guide for submitting datasets in the SEND format.
Flexible and timely CDISC SEND dataset creation and quality review services to support FDA IND submissions of in-scope nonclinical study data.
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…
Rare diseases are a public health priority. FDA has launched several programs and a final guidance to address the unmet need for orphan drugs.
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