Imported bulk drugs
Executive Summary
FDA Commissioner Henney will testify at June 8 House Commerce/Oversight Subcommittee hearing on importation of "counterfeit or substandard" bulk drugs. Commerce Committee Chairman Bliley (R-Va.) recently sent a letter to Henney describing the findings of the committee's investigation into bulk gentamicin imported from China (1"The Pink Sheet" May 15, p. 14)
You may also be interested in...
Bliley Requests FDA Plan To Link Bulk Drug Imports With GMP Compliance
Rep. Bliley (R-Va.) is asking FDA to formulate a plan to provide import inspectors with access to good manufacturing practices compliance information to determine whether bulk drugs should be detained.
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