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The FDA is recommending that sponsors submit more detailed race and ethnicity data with their applications, compared to recommendations from a previous international harmonization guideline. Read More
Drugmakers have expressed concern about the German government’s proposal to restrict drug pricing — contending that the measure penalizes research and development. Read More
The FDA withdrew a rule proposed in 2001 that would have required the public disclosure of certain data related to unapproved human gene therapy or the transplantation of non-human tissues to humans from companies seeking approval of investigational new drugs. Read More
The HHS inspector general’s office laid out its agenda for the fiscal year, planning new and expanded reviews of the FDA’s oversight of blood establishments and laboratory-developed diagnostics; management of IT modernization initiatives; and its use of prescription drug user fees. Read More
After the FDA clamped down on its facilities most of the year, Lupin has received clearance from the agency to produce drugs again at its site in Goa, India. Read More
As part of its clinical trial data auditing initiative, the Chinese Food and Drug Administration verified data from an initial set of 55 clinical trials, focusing mainly on large, international drugmakers. Read More