Allergy Bioequivalence No “Day In The Park”; FDA Seeks Only One Study
FDA is recommending one traditional study design for demonstrating bioequivalence in NDAs and ANDAs for nasal aerosols and sprays seeking a seasonal allergic rhinitis indication
You may also be interested in...
The Generic Pharmaceutical Association is requesting that FDA approve generic antihistamine nasal sprays that are different in design from the reference drug's container closure system
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