Day: January 9, 2025

The U.S. Food and Drug Administration (FDA) approved 50 new drugs last year, which is at par with the average of about 50 new drug approvals each year that the FDA has maintained over the last decade. There are some trends that have continued this year and could help developers strategize for the years to … Read more

The FDA’s new year gift to the industry is a record-breaking reading assignment; it released 31 Guidance documents on the first Monday and Tuesday of the year. In an unprecedented data dump of sorts, the guidance documents span all centers at the Agency. This is not normal by any standards but how does it impact … Read more