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National Right to Try Legislation Passes Congress

USA - May 23 2018 On May 22, 2018, the United States House of Representatives passed 250-169 the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Mathew Bellina...

Abeba Habtemariam, Daniel A. Kracov, Pari Mody, Elizabeth Trentacost.


Trump Administration Issues Blueprint to Lower Drug Prices and Reduce Out-Of-Pocket Costs

USA - May 14 2018 On May 11, the Trump Administration unveiled its much anticipated plan for reducing drug prices and patient out-of-pocket costs, with a "Blueprint"...

Abeba Habtemariam, Rahul Khara, Vicky Gormanly, Ashley Bender, Jeffrey L. Handwerker, Pari Mody, Steven Benz, Dr. John McInnes, Catherine Brinkley-Talley, Nicole M. Leon, Elizabeth Trentacost, Rosemary Maxwell, Thomas A. Gustafson, John Gould, Matthew T. Fornataro.


FDA Objects to Branded Pre-Approval YouTube Video

USA - January 3 2017 We thought our readers might be interested in a recent Untitled Letter that FDA sent to Zydus Discovery DMCC, the US agentsubsidiary of Indian...


Final Rule Expands US ClinicalTrials.gov Requirements

USA - September 23 2016 On September 16, 2016, the Department of Health and Human Services (HHS) issued a final rule implementing section 402(j) of the Public Health Service...

Daniel A. Kracov.


Time for a Reboot: FDA Issues Draft Guidance on When to Submit a 510(k) for a Software Change to an Existing Device

USA - September 7 2016 In early August 2016, the US Food and Drug Administration’s (FDA or Agency) Center for Device and Radiological Health (CDRH) issued a Draft Guidance...

Abraham Gitterman, Abeba Habtemariam, Victoria M. Wallace, Jennifer B. Madsen, Daniel A. Kracov.