Home » FDA Bioequivalence List Gains 38 New Draft Guidances
FDA Bioequivalence List Gains 38 New Draft Guidances
The FDA has provided a plethora of new guidances to drugmakers looking to demonstrate bioequivalence for their products, with 38 new product-specific documents and six revised ones.
The documents posted last week address a range of conditions, including transfusional hemosiderosis, cystic fibrosis and non-small cell lung cancer. They cover 20 oral medications, 11 topicals, two injectables, four inhalation treatments and one gel.
The full list of guidances can be accessed here: www.fdanews.com/04-14-16-BioequivalenceGuidances.pdf.
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