Recording: Novel Excipient Review Pilot Program Overview and Q&A
Recording from Wednesday, October 27, 2021 The Center for Drug Evaluation and Research (CDER) has launched the voluntary Novel Excipient Review Pilot Program (Pilot...
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The Importance of Excipient Functionality Webinar
Recording from June 9, 2021 There is increasing awareness of the important role that excipient functionality plays in drug formulations, both in existing and in new...
Excipients & Upstream/Downstream Manufacturing Processes in Biologic Drug Products Recording
Recording from Wednesday, June 30, 2021 The growth in biologic drug development has been dramatic in the last 10 years and is set to continue in the future....
Innovations in Pharmaceutical Coating Development
Recording from Wednesday, May 12, 2021 Webinar Overview There have been some major advances over the last 20 years in the use of polymeric excipients for film...
Role of Excipients in Continuous Manufacturing of Solid Oral Dosage Forms
Recording from Wednesday, April 21, 2021 Continuous manufacturing is a hot topic within the pharmaceutical industry and with the FDA. Pharmaceutical companies are...
Vision for FDA’s Inactive Ingredient Database in 2020 and Beyond
Recording from Wednesday, September 16, 2020 Excipients, the inactive ingredients in pharmaceutical products, are essential drug product components that facilitate...
Novel or Not? Our Inadvertent Journey Filing a Novel Excipient
Recording from Wednesday, July 22, 2020 This webinar was a first-hand account of the challenges to realizing, determining, and confirming the novel status of an...
Toxicology for the 21st Century: What is in the Box for Excipients?
Recording from Wednesday, July 8, 2020 The limitations of animal-based toxicology to predict human health threats are widely recognized. We also are discovering...
Clinical Relevance: Why are Enteric Coatings Failing In Vivo?
Recording from Wednesday, June 17, 2020 Over the last 70 years many cases of in vivo failure of enteric coated (EC) formulations have been reported. EC products...