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FDA
FDA Public Meeting on Training Health Care Providers on Pain Management and…
In 2012, FDA instituted a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting (ER/LA) opioids that…
Senate HELP Hearing on FDA User Fee
On March 21, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on Food and Drug Administration…
FDA Under Pressure to Speed Up Generic Approvals
As has been reported, the FDA is under pressure to speed up approval of generic medicines. In response, the FDA released data…
FDA Public Workshop on Opioid Training
The Food and Drug Administration (FDA) has announced a public workshop to obtain input on issues and challenges associated with…
Will There Be an Uptick in FDA NDA Approvals This Year?
Late last year, John Jenkins, director of the FDA’s Office of New Drugs told attendees at an event that the decline in new drug…
Senate Holds Confirmation Hearing on Gottlieb
On April 5, 2017, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a confirmation hearing on the nomination…
OPDP Picks Up Steam on Enforcement Letters
After a fairly slow 2016, the United States Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP)…
CDER 2017 Guidance Agenda
In January, FDA’s Center for Drug Evaluation and Research (CDER) released its annual guidance agenda, announcing the new and…
A Last Hurrah as CDRH Issues Guidances Before Obama’s Departure
In a last-minute attempt to put a permanent mark on the life sciences (and specifically, the medical device) industry, the…
Dr. Janet Woodcock on the Opioid Epidemic
The United States Food and Drug Administration (FDA) offers a podcast series, known as the Director’s Corner, that features the…