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FDA
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…
FDA Public Meeting on Training Health Care Providers on Pain Management and…
In 2012, FDA instituted a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting (ER/LA) opioids that…
Senate HELP Hearing on FDA User Fee
On March 21, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on Food and Drug Administration…
FDA Under Pressure to Speed Up Generic Approvals
As has been reported, the FDA is under pressure to speed up approval of generic medicines. In response, the FDA released data…
FDA Public Workshop on Opioid Training
The Food and Drug Administration (FDA) has announced a public workshop to obtain input on issues and challenges associated with…
Will There Be an Uptick in FDA NDA Approvals This Year?
Late last year, John Jenkins, director of the FDA’s Office of New Drugs told attendees at an event that the decline in new drug…
Senate Holds Confirmation Hearing on Gottlieb
On April 5, 2017, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a confirmation hearing on the nomination…