Drugmakers Seek Clarification on Use of Liquids, Foods as Drug Delivery Vehicles

Genentech wants the FDA to amend or clarify parts of its draft guidance on the use of liquids or soft foods as drug administration vehicles.

In written comments to the agency, Genentech noted that the requirements in the guidance lean more toward NDAs even though the guidance covers all stages of development. It suggested that the FDA clarify its requirements for the IND-phase, calling it a critical issue.

“We recommend that phase-appropriate expectations for clinical development be included in the document,” the company said.