IND Export Requirements Simplified In FDA Final Rule
Executive Summary
A final rule issued by FDA simplifying requirements for investigational new drug exports prohibits transshipment of drugs from a "listed" country to an "unlisted" country where the drug does not have market authorization, but otherwise includes few changes over the proposed rule issued in 2002
You may also be interested in...
FDA Investigational Drug Export Rule Encourages IND, Requires Certification
Firms exporting investigational drugs may want to obtain INDs for the products even though the designation is not required, FDA said in a 1proposed rule published in the Federal Register June 19
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials