Expanded IND Guidance Threatens Supplement Research, Innovation
This article was originally published in The Tan Sheet
Executive Summary
Recent FDA guidance indicating that dietary supplement clinical studies with disease endpoints require an IND application could render the sale of some new dietary ingredients in foods unlawful, CRN argues. The expanded scope of FDA’s requirements for IND applications further stifles innovation by adding unnecessary regulatory barriers and costs, CHPA and others add in comments to the agency.
You may also be interested in...
J&J Consumer Sales Slip Even As Recalled Brands, Seasonal Items Reach Stores
J&J reports worldwide consumer sales dipped 0.6% to $3.6 billion despite retailers buying more upper respiratory and analgesic products to prepare for the cough and cold season. But in key OTC categories the firm is regaining market share it lost when its iconic brands were temporarily not available.
Ensuring Leading Position For GSK Consumer Products Touted In Management Shift
GlaxoSmithKline restructures its management to ensure adequate focus on its three core areas, pharmaceutical, vaccine and consumer. Consumer product sales fell 3% to $1.72 billion in the third quarter due to continuing supply interruptions and generally weaker markets.
Ensuring Leading Position For GSK Consumer Products Touted In Management Shift
GlaxoSmithKline restructures its management to ensure adequate focus on its three core areas, pharmaceutical, vaccine and consumer. Consumer product sales fell 3% to $1.72 billion in the third quarter due to continuing supply interruptions and generally weaker markets.