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Two stakeholders request changes to an FDA draft guidance on risk management plans to mitigate the potential for drug shortages.[ Price : $8.95]
FDA posts a draft guidance entitled Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations Premarke...[ Price : $8.95]
Federal Register notice: FDA grants a 10/17-19 hearing request to review and vote on whether agency approval for Covis Makena (hyd...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of 30 NDAs from multiple applicants after they notified the agency that the produc...[ Price : $8.95]
FDA authorizes personal sound amplification products as over-the-counter hearing aids for some consumers.[ Price : $8.95]
FDA publishes an updated guidance on replacement reagent and instrument family policy for in vitro diagnostic devices.[ Price : $8.95]
FDA warns Northridge, CA-based Verde Cosmetic Labs about CGMP violations in its production of finished drugs.[ Price : $8.95]
The HHS Office of Inspector General says the National Institutes of Health failed to enforce federal requirements that clinical tr...