But it also needs to give its approval for test and delivery flights, and the agency has set the pace for other countries.
The FAA's approval of the plan allows for limited test flights for two aircraft equipped with prototype versions of the battery fix.
The FDA advisory panel meeting on Monday is widely seen as a test of how high the bar for approval is for cancer drugs.
The FDA said it has no record of Pathway Genomics' test being submitted to the agency for approval and that it could not provide any information about the agency's possible actions.
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Generally, test kits sold to other laboratories do require approval.
Let me tell ya, very little, certainly not even close to even a quarter of a billion dollar, especially if all test will require a new FDA510K medical device approval.
Winning approval for Glybera proved particularly challenging because the company was only able to test it on 27 patients in clinical trials, due to the rarity of the condition.
Boeing is still waiting for approval from the Federal Aviation Administration (FAA) on potential fixes to begin test-flying the 787, but it continues to receive orders for the Dreamliner, with Air Berlin announcing an order for 15 units on Tuesday.
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This is because a test ban raised some difficult technical challenges that needed to be surmounted before Senate approval.
Instead of relying exclusively on focus groups and management approval for new recipes, chefs now also go into restaurants for up to a month, test new dishes on real customers and get feedback from the people who cook and serve the meals.
Mr Grade also introduced the concept of the Public Value Test which will be formally applied before new services, projects and changes, are given approval.
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