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www.fdanews.com/articles/176290-fda-bioequivalence-list-gains-38-new-draft-guidances

FDA Bioequivalence List Gains 38 New Draft Guidances

April 20, 2016

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.