On August 6, the Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI) held a joint workshop to explore “Artificial Intelligence in Drug & Biological Product Development.”
The workshop...more
The American public knows that 2024 is a critical election year, with the next race for the presidency in November expected to be another face-off between President Biden and former President Trump. What the majority may not...more
Over the course of 2020, the Food and Drug Administration (FDA) released numerous guidance documents covering diverse areas and aimed at increasing the availability of various medical products to prevent, treat, and diagnose...more
11/17/2021
/ CDRH ,
Center for Drug Evaluation and Research (CDER) ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Goods or Services ,
Healthcare ,
Infectious Diseases ,
Medical Devices ,
Public Health Emergency ,
Relief Measures ,
Retail Market ,
Temporary Regulations
Clinical trial sponsors and principal investigators can consider themselves on notice that the Food & Drug Administration (FDA) is poised to ramp up enforcement activity relating to responsible parties’ obligations regarding...more
A lot has happened since we last addressed new biosimilar developments in January 2018. In the intervening months, there have been many significant developments related to FDA’s implementation of an efficient regulatory...more