FDA Archives

Rare disease drug development: Time for a new approach?

Written by

A rare disease is one that affects a small percentage of the population.

A limited patient population is a key challenge in rare disease drug development. Professor Shein-Chung Chow of Duke University School of Medicine, USA and his research partners explore innovative approaches to overcome this challenge. These include using external control, selecting appropriate study endpoints, and justifying sample size based on probability statements. They propose the use of a complex innovative two-stage […]

A matter of choice: Free to choose medicine in the 21st century

Written by

Bartley J Madden’s work on a structural improvement to the US FDA’s drug approval process has spanned 20 years.

The US Food and Drug Administration’s system for medicine approval is lengthy and expensive, and only 1 in 12 drugs in human clinical trials obtain approval. Bartley J Madden of the Madden Center for Value Creation at Florida Atlantic University proposes an alternative free to choose medicine (FTCM) pathway. He suggests that with the advice of their doctors, patients should […]

Informed options trading prior to the FDA approval

Written by

Persistent illegal trading in options in manufacturers for vaccines on the stock exchange following FDA approval

FDA approval of new drugs, devices and vaccines New drugs, devices, and vaccines undergo rigorous testing before being made available to the public. Testing begins with pre-clinical tests on animals. Subsequently, a manufacturer can submit an investigational new drug application (IND) to the FDA. The IND will contain detailed information about the proposed drug and the proposed human clinical trials. […]