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2. List of Guidances for Statistics in Regulatory Affairs

   en.wikipedia.org/wiki/List_of_Guidances_for...

   EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10] FDA-2015-D-1376: Leveraging existing clinical data for extrapolation to pediatric uses of medical devices. Guidance for Industry and Food and Drug Administration Staff. [11] ICH E5 (R1): Ethnic factors in the acceptability of foreign clinical ...

3. Common Technical Document - Wikipedia

   en.wikipedia.org/wiki/Common_Technical_Document

   The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond. [ 1 ] Major Synopsis

4. Electronic common technical document - Wikipedia

   en.wikipedia.org/wiki/Electronic_Common...

   The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 ...

5. European Medicines Agency - Wikipedia

   en.wikipedia.org/wiki/European_Medicines_Agency

   The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).

6. Trial master file - Wikipedia

   en.wikipedia.org/wiki/Trial_master_file

   The minimum essential documents that are required for the registration of pharmaceutical products designed for human use are specified in the document 'ICH Good Clinical Practices,' published in 1997 by the ICH [2] Example ICH essential documents that would be required in any US, EU or Japan based clinical trial would include: signed protocol ...

7. Sleep apnea impacts brain in ways that may affect cognitive ...

   www.aol.com/lifestyle/sleep-apnea-impacts-brain...

   A new study links sleep apnea to changes in key brain regions related to memory. Image credit: Maskot/Getty Images. This article originally appeared on Medical News Today

8. Victims ‘shocked’ after Biden grants clemency to ‘kids-for ...

   www.aol.com/victims-shocked-biden-grants...

   Victims of major public corruption cases in Pennsylvania and Illinois are angry that President Joe Biden granted clemency this week to two convicted officials.. The commutations were announced ...

9. Routine prenatal test revealed her ‘hidden cancer.’ A study ...

   www.aol.com/news/routine-prenatal-test-revealed...

   A woman got routine bloodwork during her second pregnancy and was shocked when the test results came back: It suggested her baby was healthy, but there was something unusual about her own health.