FDA And The Transition: Reading The LDT Leaves
FDA’s decision to hold off on finalizing its guidance on oversight of lab-developed tests is an acknowledgement of the new US political dynamics after the Nov. 8 elections. It may also be an important signal of where early attention will fall at FDA after the transition: on the devices, not drugs.
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US FDA’s latest effort to provide guidance for consumers on pharmacogenomics tests underscores the challenges the agency faces in the absence of a clear regulatory framework for lab-developed tests – and with no easy mechanism to update labels for off-patent drugs.
Republican Congress, Trump Policies May Seek To 'Undo' FDA Device Safety Guidances; LDT Plan First To Go
Emboldened by a Republican victory in the White House, GOP members of Congress are already putting the screws on federal agencies to back off on health and safety regulations and guidances for products, with some success – for example, FDA's Nov. 18 decision to shelve its proposed laboratory developed test guidance in final form seems to be a response to the new political reality in DC.
After years of wrangling over lab-developed test regulations with laboratory lobbyists, FDA has put its plans to finalize a guidance that lays out its oversight framework for LDTs on hold as a new Congress and a new deregulation-focused president-elect is set to take the helm.