Happy multi-generation family holding Thanksgiving turkey together at dining table.

Hope at This Time of Giving Thanks

Just look around, watch the television, read the newspaper, and what do you see?  Seems like very few reasons to be thankful.  School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth.  Climate change is threatening the future of our children, and the environmental controls have been set back 50 years as the oceans continue to rise,

Athlete Jumping over Hurdles

Compounding vs. FDA Approved Product Presents a Conundrum Regarding the Accelerated Approval of Hydroxyprogesterone for Delay of Preterm Labor

Sue Sutter of the Pink Sheet wrote an article on September 23 entitled “Makena’s Accelerated Approval Will Hang In Balance at US FDA Panel Meeting In October” (here [subscription required]).  The crux of the article deals with how FDA will handle accelerated approval when the required postmarketing confirmatory study fails to meet its endpoints.