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Revised Draft Guidance Calls for Greater Use of Electronic Data

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US regulators have released a new draft guidance document aimed at providing industry with insight on the use of electronic source data in clinical investigations.The guidance, set to be published on Read More...

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Revised FDA Manual Provides Statistical Reviewers with Standardized Template

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A revised Manual of Policies and Procedures (MAPP) developed for US Food and Drug Administration (FDA) drug review staff instructs them on how to assess statistical reviews using good review practices Read More...

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New EMA Guideline on Diabetes Focuses on Cardiovascular Risks

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The European Medicines Agency (EMA) has released a new guideline aimed at assisting sponsors in the development of products to treat or prevent diabetes mellitus. The guideline makes important changes Read More...

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ICH Releases Update for E14 Guideline on Clinical Evaluation of Non-Antiarrhythmic Drugs

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The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has released an updated version of its Efficacy (E) 14 Guideline, Read More...

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RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more

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News

Revised Draft Guidance Calls for Greater Use of Electronic Data

Revised FDA Manual Provides Statistical Reviewers with Standardized Template

New EMA Guideline on Diabetes Focuses on Cardiovascular Risks

ICH Releases Update for E14 Guideline on Clinical Evaluation of Non-Antiarrhythmic Drugs

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