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Medical device expert Marcelo Trevino analyzes for Med Device Online the results from the first 100 FDA inspections under the new ...[ Price : $8.95]
FDA releases a guidance that is intended to assist industry in the submission of datasets from clinical studies that evaluate immu...[ Price : $8.95]
Sen. Ron Johnson (R-WI) launches a new investigation into federal handling of Covid-19 vaccine safety issues, seeking records from...[ Price : $8.95]
A Buchanan petition on behalf of an interested client asks FDA to take specified actions to determine whether there is a patient s...[ Price : $8.95]
FDA asks manufacturers of generic Accutane to update the drugs labeling.[ Price : $8.95]
FDA tells UniQure that data from its ongoing Phase I/II study of AMT-130 could serve as the primary basis for a BLA seeking accele...[ Price : $8.95]
FDA and the African Medicines Agency sign a Statement of Cooperation establishing a formal framework for collaboration between the...[ Price : $8.95]
FDA accepts for review a BLA resubmission from Outlook Therapeutics seeking approval of ONS-5010/Lytenava (bevacizumab-vikg) for t...