Improving TEA Process Needs More Than Review Deadlines Proposed In Senate
This article was originally published in The Tan Sheet
Executive Summary
While manufacturers and other stakeholders recommend that FDA eliminate redundant steps and allow more transparency in the TEA process, Senate HELP Committee draft legislation focuses on deadlines for application reviews.
You may also be interested in...
All OTC Ingredient TEAs Get Review Deadlines In Senate Draft Bill
Senate HELP Committee leaders release a draft bill that expands on changes proposed in the House’s Sunscreen Innovation Act by requiring deadlines for FDA review of all OTC ingredient TEAs. In a draft bill, Chairman Tom Harkin and other HELP members propose setting “reasonable” deadlines for TEA reviews.
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.