Tag Archives: Center for Drug Evaluation and Research

Breakthrough Drug Initiative Success Creates Manufacturing Challenges

The breakthrough drug initiative has accelerated the development and approval of highly effective therapies, enabling important new medicines to reach patients sooner, according to Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER). Twelve breakthrough drugs have been approved over the past two years for several critical conditions in addition to cancer, […]
Posted in FDA, Manufacturing | Also tagged , , , , | Leave a comment

Breakthrough Therapy Program Exceeds FDA’s Expectations

The two-year-old initiative to accelerate the development and approval of highly effective drugs and biologics has enabled a number of important new medicines to reach patients sooner,  according to Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER). Twelve breakthrough drugs have been approved over the past two years, for several critical […]
Posted in FDA, Op-Ed, Regulatory, Safety | Also tagged , , , | Leave a comment

Feds Threaten to Pull ProAmatine for Lack of Postmarket Data (Updated 8/18)

Image via Wikipedia FDA on Monday announced that it was looking to withdraw approval for the low-blood-pressure treatment midodrine hydrochloride because the companies manufacturing the drug failed to provide data from post-approval studies. The kicker: The drug was approved 14 years ago. FDA gave midodrine hydrochloride—branded by Shire as ProAmatine and produced by a half-dozen […]
Posted in FDA | Also tagged , , , , , , , | 1 Comment

Adverse Event Reports Go Digital Only

Image via Wikipedia FDA, this morning, walked media through its proposed regulations requiring that pharma companies submit post-market adverse event reports through an electronic format. This is being done to help eliminate time and cost wasted on paper submissions. “This change will enhance FDA’s ability to rapidly identify new safety concerns and share safety information […]
Posted in Regulatory, Safety | Also tagged , , , , | 1 Comment

Woodcock Under Investigation

Image by Getty Images via Daylife An FDA director has come under fire by a generics firm claiming that the director of the Center for Drug Evaluation and Research favored a competitor in a wanton act of conflict of interest. The Wall Street Journal this morning broke the story that Janet Woodcock is under investigation […]
Posted in Strategy | Also tagged , , , , , | Leave a comment
  • Categories

  • Meta