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FDA
Is FDA Building its Talent Pool?
We recently reported on the Senate’s passage of the FDA Reauthorization Act (FDARA) which renews and enhances the FDA drug,…
A Murky Future for Off-label Promotion: New Leadership at the FDA Brings…
On May 11, 2017, Dr. Scott Gottlieb was sworn in as the U.S. Food and Drug Administration’s latest Commissioner. Since that time,…
FDA Considering Removing Regulatory Obstacles to Generic Competition
Mid-July 2017, the United States Food and Drug Administration held a public meeting to discuss options and steps to encourage…
FDA Issues Two Proposed Studies on Disclosures for Advertising
Last month, the FDA issued two proposed studies on disclosures for advertising: one for general advertising and another for…
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…