eCTD submission

CDER Plans 90 Guidance Documents in 2015, Including Bio similarity and Social Media

The US Food and Drug Administration”s (FDA) Center for Drug Evaluation and Research (CDER) has released a new list of 90 guidance documents it plans to publish in 2015, including several long anticipated and eagerly awaited by members of the pharmaceutical industry.


http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM417290.pdf

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KnetAdmin

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