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FDA and Health Canada announce a 10/8 regional public consultation on recent International Council for Harmonization activities an...[ Price : $8.95]
FDA says NDA and ANDA sponsors who submitted study data developed by Indias Panexcell Clinical Lab or Synchron Research Services m...[ Price : $8.95]
Johnson & Johnson reports new data showing increased protection against Covid-19 when a booster shot of its vaccine is administere...[ Price : $8.95]
FDA warns the Fibromyalgia Treatment Group it is selling unapproved new drugs.[ Price : $8.95]
FDA posts a draft guidance entitled Questions and Answers on Quality-Related Controlled Correspondence for generic drug developers...[ Price : $8.95]
FDA approves a Samsung Bioepis and Biogen BLA for Byooviz (ranibizumab-nuna), the first biosimilar version of Genentechs age-relat...[ Price : $8.95]
Federal Register notice: FDA makes available on its Web site certain final administrative orders, including for over-the-counter (...[ Price : $8.95]
FDA issues an alert about the potential for false positive results with Abbott Moleculars Alinity m SARS-CoV-2 AMP Kit and Alinity...