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FDA
US Senate Passes FDA User Fees, Right to Try and Opioid Legislation
After many months of debate, both chambers of Congress passed the FDA User Fee Package. This comes after the Senate passed its…
FDA Orphan Drug Modernization Plan Released
In late June 2017, the U.S. Food and Drug Administration (“FDA”) unveiled a strategic plan to both eliminate the agency’s…
New Report Releases Strategies to Reduce Opioid Epidemic
The National Academies of Sciences, Engineering, and Medicine recently released a report, requested by the United States Food and…
FDA Hearing on Innovation and Access
Earlier this week, the Food and Drug Administration (FDA) held a public hearing entitled “The Hatch-Waxman Amendments: Ensuring a…
United States House of Representatives Passes PDUFA
On Wednesday, July 12, 2017, the United States House of Representatives passed a bill via voice vote to reauthorize the…
FDA Drug Approvals on an Uptick
Already in 2017, the FDA has approved a number of new drugs, which Regulatory Focus points out as a trend away from the low number…
Gottlieb Establishes Committee to Address Opioid Crisis
FDA Commissioner Scott Gottlieb – sworn in on May 11, 2017 – has established a steering committee to address the opioid crisis and…
FDA Office of Regulatory Affairs to Undergo Realignment
In a March hearing before the House Energy & Commerce Committee, FDA’s Jeffery Shuren announced the FDA’s Office of Regulatory…
Senate HELP Committee Advances FDARA
On Thursday, May 11, 2017, the Senate Health, Education, Labor, and Pensions (HELP) Committee advanced an amended version of the…
Fighting Back – Pharma Objects to FDA’s Last Minute Obama-Era Guidances
As we noted in last month’s issue, the FDA issued a slew of last-minute Obama Administration guidances. Overlooked among all the…