March 13, 2014
FDA clarifies recommendations for injectable drug products packaged in vials and ampules.
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March 11, 2014
HHS plan makes progress in ensuring availability of safe vaccines.
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March 6, 2014
Agencies extend successful pilot program to further harmonization of QbD topics.
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March 4, 2014
New guidance from FDA asks for documentation of CMC postapproval manufacturing changes.
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March 4, 2014
Novartis calls for more research to understand and find treatments for rare disease.
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February 26, 2014
Moody's Investor Service reports AbbVie, Amgen, and Roche are the most exposed to biosimilar competition.
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February 25, 2014
FDA revises interpretation of the five-year NCE exclusivity provisions for certain fixed-combination drug products.
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February 19, 2014
FDA and EMA set up regular meetings to harmonize drug safety actions.
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February 19, 2014
FDA provides recommendations for submitting analytical procedures and methods validation data.
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