FDA

TWiV 651: FDA rules with Denise Esposito

Daniel Griffin provides a clinical report on COVID-19, then former FDA Chief of Staff to the Commissioner Denise Esposito joins us to explain the challenges in approving vaccines, antiviral drugs, and diagnostic tests during a pandemic, followed by answers to listener questions. Click arrow to playDownload TWiV 651 (98 MB .mp3, 164 min)Subscribe (free): iTunes, Google Podcasts, RSS, email Become …

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Influenza A (H1N1) 2009 vaccine: efficacy and safety

There have been many interesting responses to my recent post, “Are you receiving the influenza 2009 H1N1 vaccine?” Some individuals have already been immunized or plan to do so shortly. Others are concerned about the safety and efficacy of the monovalent preparations. As pointed out recently in a Nature editorial, “Mass-vaccination campaigns…must take public concerns …

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