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Regulatory Affairs Blog Posts

September 20, 2022 Regulatory Affairs

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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September 14, 2022 Regulatory Affairs

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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August 26, 2022 Regulatory Affairs

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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August 25, 2022 Regulatory Affairs

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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August 25, 2022 Regulatory Affairs

FDA – Tobacco Products: Principles for Designing and Conducting Tobacco...

FDA – Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception…

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August 25, 2022 Regulatory Affairs

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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August 23, 2022 Regulatory Affairs

EMA: Monkeypox

The European Medicines Agency (EMA) is supporting the European Union’s (EU) response…

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August 22, 2022 Regulatory Affairs

FDA Issues Revised Draft Guidance on Charging for Investigational Drugs...

August 2022 Draft Guidance This guidance provides information for industry, researchers, physicians,…

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