Newsletter - October 20, 2022
FDA Starts a New Limited Program for Advancing RWE
Today FDA announced a new program for advancing Real World Evidence (RWE) aimed to develop new approaches for using RWE for labeling changes, new indications for previously approved drugs, or to support post-market commitments. The program will select a few sponsors who want to use RWE...Read More
Off-Label Use of Diabetes Drug for Weight Loss: Anecdotes to RWE
A diabetes drug with a side-effect of weight loss has become popular for its off-label use as a weight-loss drug presenting a classic test case where medical experience could have potential applications for RWE-driven new indications. The drugs of the class GLP-1 RA (Glucagon-Like Peptide 1 Receptor Agonist) are...Read More
FDA Starts a New Limited Program for Advancing RWE
Today FDA announced a new program for advancing Real World Evidence (RWE) aimed to develop new approaches for using RWE for labeling changes, new indications for previously approved drugs, or to support post-market commitments. The program will select a few sponsors who want to use RWE...Read More
Off-Label Use of Diabetes Drug for Weight Loss: Anecdotes to RWE
A diabetes drug with a side-effect of weight loss has become popular for its off-label use as a weight-loss drug presenting a classic test case where medical experience could have potential applications for RWE-driven new indications. The drugs of the class GLP-1 RA (Glucagon-Like Peptide 1 Receptor Agonist) are...Read More
