FDA Puts Conditions on Lilly Covid Drug After Factory Issues (1)
By Anna Edney
Nov. 10, 2020, 4:21 PM
Eli Lilly & Co. is required to hire an outside firm to test batches of its experimental Covid-19 therapy made at one of its U.S. plants, after regulators raised concerns about the facility earlier this year.
Lilly must also retain an independent third party to vet quality-testing data and other records as the treatment is manufactured at the facility in Branchburg, New Jersey, according to a letter on Monday from the Food and Drug Administration granting an emergency authorization for the drug’s use in treating Covid-19.
If a review discovers any issues, Lilly would be required to hold off on ...