Challenges, Lessons Learned, and Guidance for the Clinical Development of...
It comes as no surprise to any pharmaceutical or biotech company that…
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How to Comply with the Nitrosamine Regulations for Your New...
Introduction: Are you in the development phase for your medicinal product? Have…
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FDA Announces Availability of Multiple Draft Guidances – Drug Information...
Today, FDA announced the availability of the following draft guidances for industry,…
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FDA Issues FY2021 Report on the State of Pharmaceutical Quality
FDA Issues FY2021 Report on the State of Pharmaceutical Quality: The Office…
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FDA – Tobacco Products: Principles for Designing and Conducting Tobacco...
FDA – Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception…
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FDA Designates Empirically Based Bayesian Emax Models for Dose Finding...
FDA Designates Empirically Based Bayesian Emax Models for Dose Finding as ‘Fit-For-Purpose’:…
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EMA: Monkeypox
The European Medicines Agency (EMA) is supporting the European Union’s (EU) response…
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FDA Issues Revised Draft Guidance on Charging for Investigational Drugs...
August 2022 Draft Guidance This guidance provides information for industry, researchers, physicians,…
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