ANDA Easily Correctable Deficiencies Focus On Quality
FDA program allows generic sponsors to keep applications on track, but they must respond quickly with a well-formatted cover letter.
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NMEs and novel biologics will see reviews allotted two additional months under the revised model launching Oct. 1. Industry expects to gain more communication and first-cycle approvals, while FDA hopes it can receive more complete applications at submission and improve transparency.
Virtual kick-off meetings may be necessary, but preparations continue in anticipation of the formal talks to reauthorize the prescription drug, generic drug and biosimilar user fee programs.
Agency officials can now discuss the ideas that have been accepted, though not in great detail.