Sanofi comments on otitis media guidance
Executive Summary
Sanofi-Aventis was the only company to submit comments on FDA's Acute Bacterial Otitis Media draft guidance. The company initiated its own pediatric-specific program in ABOM in 2002, and its comments, the company said, "come from practical and recent experience." Sanofi cautioned that there are challenges in conducting superiority trials in that the enrollment of patients with sufficient morbidity to demonstrate treatment effect in placebo-controlled studies may not be possible. Sanofi also said the guidance should make clear the relationship between criteria for enrollment and outcomes, and that the methodology to manage the uncertainty in clinical diagnosis in large studies, where tympanocentesis on all patients cannot be performed, needs to be addressed
You may also be interested in...
GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows
A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.
Roche Gets Adjuvant ALK+ Lung Cancer To Itself With Alecensa Approval
The US FDA cleared Roche’s supplemental approval request for ALK inhibitor Alecensa in ALK-positive non-small cell lung cancer following tumor resection.
MoCRA’s Adulteration Ambiguity And FDA’s New Cosmetic Recall Authority: Attorney Weighs In
The US FDA should use guidance or rulemaking to clarify MoCRA provisions related to adulteration, Amin Wasserman Gurnani attorney Angela Diesch suggested at the Independent Beauty Association’s Cosmetics Convergence Spring Symposium. Attendees also sought her take on whether the agency’s new recall authority is likely to spell an increase in cosmetic product recalls.