MAJOR AND SWEEPING CHANGES PLANNED FOR FDA (Orthopedics This Week)
Like the British navy sailing to the Falkland Islands, the Food and Drug Administration (FDA) has been signaling that big changes are afoot in 2014 in how the agency will be reorganized.
In late 2013, the agency announced it would need to “realign” its programs to keep up with “unparalleled challenges” posed by advances in science, globalization and product complexity.
On February 4, 2014, Regulatory Focus writer Alexander Gaffney reported that FDA Commissioner Margaret Hamburg, M.D. has unveiled major and sweeping changes to the agency which will see the agency’s many divisions reorganize in an attempt to “become more specialized and able to address increasing scientific and regulatory complexity.”
He reports that in a memo to all heads of FDA’s regulatory centers, Hamburg said that recommendations made by an internal “Program Alignment Group” (PAG) are being used to “chart a course for modifying Agency functions and processes to improve communications and collaboration and to clarify roles, responsibilities and decision rights across all agencies.”
Commodity-Based and Vertically-Integrated
Hamburg said the PAG had...
