FDA grants Boehringer Ingelheim and Eli Lilly a fast track designation for Jardiance (empagliflozin) and its use to reduce the risk of kidney disease ...
A day after FDA commissioner Stephen Hahn was criticized during a 3/11 hearing about delays in testing amid the coronavirus outbreak, National Institu...
FDA releases the FDA-483 with five observations from an inspection at Indias Biocon Limited API manufacturer.
FDA issues a guidance on its implementation of the 510(k) third party review program.
FDA releases the FDA-483 with seven inspection observations from the Maitland Labs of Central Florida outsourcing facility.
Federal Register notice: CDER has announced that it will begin supporting new e-submission standards for Animal Rule submissions effective 3/15.
Federal Register notice: FDA makes available a draft guidance entitled Providing Regulatory Submissions in Alternate Electronic Format.
Four stakeholders raise varying concerns with the FDA/HHS proposal to allow some state drug importation programs.