FDA Publishes ANDA Guidance Documents

Pharmaceutical Technology Editors

The agency published four guidance documents regarding ANDAs and amendments to ANDAs.

On Oct. 2, 2017, FDA published four guidance documents expressing the agency’s views on abbreviated new drug applications (ANDAs) regarding highly purified synthetic peptides, complex products, refuse-to-receive standards, and the Generic Drug User Fee Amendments (GDUFA).

ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin, Guidance for Industry helps companies determine if a synthetic peptide drug that refers to a previously approved recombinant deoxyribonucleic acid peptide drug should be submitted as an ANDA. The guidance specifically addresses glucagon, liraglutide, nesiritide, teriparatide, and teduglutide.  

Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA provides information to companies applying for an ANDA for a complex product and how these companies can request and conduct meetings with FDA. The agency defines complex products in the guidance as those with complex APIs, formulations, or dosage forms.

ANDA Submissions–Refuse-to-Receive Standards: Questions and Answers provides answers to questions FDA has received regarding refuse-to-receive standards. General issues such as organization of an ANDA, FDA filing decisions, drug master files, product quality, and bioequivalence are addressed.

ANDA Submissions–Amendments to Abbreviated New Drug Applications Under GDUFA discusses how review goals established as part of GDUFA II apply to amendments of ANDAs or prior approval supplements. Amendment classifications and categories are addressed. The guidance also explains how amendment submission may affect review goal dates.

Source: FDA