Standardization of cockroach and mold allergens would occur under the HHS Asthma Initiative without affecting standardization efforts for latex and food allergens, CBER Laboratory of Immunobiochemistry Chief Jay Slater, MD, told FDA's Allergenic Products Advisory Committee.

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 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