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July 28, 2017
Manufacturers are seeking greater oversight of how providers reimburse for and dispense covered drugs.
July 12, 2017
A recent paper coauthored by FDA’s Lawrence Yu and Michael Kopcha describes how the industry might modernize drug manufacturing.
July 05, 2017
A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.
June 15, 2017
Congressional measures lack the support to move forward.
June 02, 2017
New reports indicate that drug prices are slowing compared to other healthcare costs.
May 23, 2017
CBER is moving forward with the development and approval of regenerative medicine advanced therapies.
May 09, 2017
FDA hopes to better use global resources and avoid duplicate inspections of foreign facilities.
User fee reauthorizations, a hiring freeze, and opioid epidemic await the new FDA commissioner Scott Gottlieb.
April 06, 2017
The role of patient advocates in shaping regulations and policy has put attention on financial and operational links between drug companies and independent health organizations.
FDA is in the center of the debate over developing and pricing new cancer therapies.