Category Archives: Approval Announcements

The White House on FDA Approval Burden – Is There a There There?

In his remarks to a joint session of Congress delivered this week, President Trump expressed the point of view that the “slow and burdensome approval process at the Food and Drug Administration keeps too many advances… from reaching people in … Continue reading

Posted in Approval Announcements, FDA Image, FDA Policy | 1 Comment

FDA – Fewer Approvals, Less to Talk About in 2016

As the year ends, it is time to look back at what has occurred during the year and what hasn’t. Let’s begin with approvals. I noted recently in a Tweet that during the months of October and November, FDA had … Continue reading

Posted in Approval Announcements, FDA Image | Comments Off on FDA – Fewer Approvals, Less to Talk About in 2016

FDA 2015 Report on New Drug Approvals – A Banner Year

Greetings from the big blizzard of 2016. With life in the slow lane for a bit, it was a good time to catch up on reading. One of those was a recently issued FDA report on the novel new drugs … Continue reading

Posted in Approval Announcements, FDA Policy | Comments Off on FDA 2015 Report on New Drug Approvals – A Banner Year

HHS Secretary Directs FDA Decision on Plan B

Plan B oral contraceptive (levonorgestrel 1.5mg), commonly known as the “morning after” pill, has been available for women over 17 for several years without a prescription.  The eventual granting of non-prescription status followed a long and somewhat tortured regulatory pathway … Continue reading

Posted in Approval Announcements, FDA Policy | Comments Off on HHS Secretary Directs FDA Decision on Plan B

The Swine Flu Vaccine is Approved – If You Build it Will They Come?

Yesterday the Food and Drug Administration announced the approval of flu vaccines for the H1N1 flu virus, popularly known as Swine Flu, being manufactured by four separate firms.  The amount of time between the initial outbreaks of H1N1 this Spring, … Continue reading

Posted in Approval Announcements | 2 Comments