What’s New in Regulations and Compliance

Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, has been chosen to lead the Center for Biologics Evaluation and Research at FDA.

The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.

While global harmonization exists, there are still differences between the US and European GMP requirements that manufacturers should know, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.

Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.

The recombinant vaccine, under the brand name Vimkunya, is recommended for persons age 12 and older who are traveling to a country or territory where there is a chikungunya outbreak.