Newsletter - February 15, 2018
Ethics of Placebo-Controlled Studies: Pediatric Study Challenged
A doctor with competing interests complained that a NIH-funded study similar to his earlier trial was unethical because it involved giving placebo to children. This prompted NIH to call an urgent meeting of the DSMB for the placebo-controlled trial and some changes to the trial to address the concerns. Read More
FDA’s Wish-List for 2018 Includes Ambitious and Achievable Goals
FDA commissioner released a list of priorities for this year that could be categorized into two broad areas: encourage domestic manufacturing, and increase the role of real world evidence (RWE) for product approval. To boost domestic manufacturing, FDA plans to focus its attention of new technologies, particularly for biotechnology products and medical devices. Read More
Ethics of Placebo-Controlled Studies: Pediatric Study Challenged
A doctor with competing interests complained that a NIH-funded study similar to his earlier trial was unethical because it involved giving placebo to children. This prompted NIH to call an urgent meeting of the DSMB for the placebo-controlled trial and some changes to the trial to address the concerns. Read More
FDA’s Wish-List for 2018 Includes Ambitious and Achievable Goals
FDA commissioner released a list of priorities for this year that could be categorized into two broad areas: encourage domestic manufacturing, and increase the role of real world evidence (RWE) for product approval. To boost domestic manufacturing, FDA plans to focus its attention of new technologies, particularly for biotechnology products and medical devices. Read More
