New York: US FDA on Friday called a federal investigation of a process that caused his own approval for new drugs for Alzheimer’s disease which has spurred criticism from parliamentarians and medical communities.
The FDA acting commissioner, Janet Woodcock, acknowledged the supervision that had been faced by the agency about the approval process for the drug, Aduhelm, which had an annual price label of $ 56,000.
He pointed to the interaction between representatives of drug developers, biogen, and agency, said some “may have occurred outside the process of formal correspondence”.