Under FDA's leadership, the International Council for Harmonisation (ICH) recently published Q13 draft guidelines on continuous manufacturing (CM) to advance the brand and generic drug industries ability to obtain approvals...more
On July 31, 2019, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) published a joint report on their efforts to support the development of and expedite access to breakthrough therapies that...more
8/5/2019
/ Biologics ,
Breakthrough Therapy Designation ,
CGMP ,
Data Management ,
European Medicines Agency (EMA) ,
Expedited FDA Approval ,
Food and Drug Administration (FDA) ,
Innovation ,
Manufacturers ,
Regulatory Agencies ,
Regulatory Standards
On November 9, FDA Commissioner Scott Gottlieb, M.D., announced that the agency launched new inspection protocols for aseptic processing of sterile drugs to be used by FDA investigators during surveillance and pre-approval...more
On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning...more
9/21/2017
/ CGMP ,
Food and Drug Administration (FDA) ,
Genetic Materials ,
Health Care Providers ,
Inspection Rights ,
Life Sciences ,
Medical License ,
Pharmaceutical Industry ,
Safety Standards ,
Stem cells ,
Warning Letters