Results For "fda"

FDA’s Lykos Rejection Delays—But Doesn’t Stop—Psychedelic Therapies Blog Post

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…

Navigating New Terrain: Joint Advice on FDA/EMA Compliance – Aligning with Evolving EU Regulations Blog Post

Sponsored Webcast: Best Practices for Simultaneous Submissions to EMA/FDA Blog Post

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…

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

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 Releases New PMDA, FDA, NMPA Validation Engines Blog Post

Pinnacle 21 by Certara announces the latest Validation Engines for submissions to Japan PMDA, US FDA, and China NMPA!

FDA SEND Dataset Requirements for Nonclinical Studies Blog Post

This white paper is a step-by-step guide for submitting datasets in the SEND format.

SEND Dataset Services for FDA IND Submissions Page

Flexible and timely CDISC SEND dataset creation and quality review services to support FDA IND submissions of in-scope nonclinical study data.

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

同じ製品であっても、欧州と米国では製造販売承認申請の内容や形式が大きく異なる場合があります。This presentation will explore the major differences between…

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

How to Navigate the FDA Landscape for an Orphan Drug Blog Post

希少疾患は公衆衛生上の優先事項です。FDA has launched several programs and a final guidance to address the unmet need for orphan drugs.