FDA Targets Complex Generic Drugs With New Draft Guidance

Regulatory NewsRegulatory News
| 02 October 2017 | By Zachary Brennan 

The US Food and Drug Administration (FDA) on Monday kicked off a two-day meeting on modernizing generic drug development and released two new draft guidance documents on complex generic drugs – an area where increasing competition can be difficult.

FDA Commissioner Scott Gottlieb spoke at the meeting on Monday morning, highlighting recent moves to establish a list of off-patent drugs that will receive expedited approval if an abbreviated new drug application (ANDA) is submitted, as well as new plans to expedite the reviews of the first three generic drugs for which competition is lacking.

In May and June, FDA approved the most generic drugs since the agency began tallying its monthly approvals, though an outstanding challenge the agency faces is multiple cycle reviews for generics. Kathleen Uhl, director of the Office of Generic Drugs, on Monday highlighted this need to decrease the number of review cycles.

Gottlieb also called for the more widespread use of modeling and simulation in the generic space, in addition to the need to streamline complex generic reviews.

New Draft Guidance on Complex Generics

The two new draft guidance documents released Monday relate to formal meetings between FDA and ANDA applicants, and ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin.

The formal meeting guidance will assist ANDA applicants and prospective applicants in generating and submitting meeting requests and the associated meeting package for complex products as envisioned by the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II), which took effect on Monday.

The other draft guidance is intended to assist potential ANDA applicants in determining when an application for a synthetic peptide drug (specifically glucagon, liraglutide, nesiritide, teriparatide and teduglutide) should be submitted as an ANDA rather than as a new drug application.

"Bioequivalence for complex generic drugs can be challenging with complex drug products that can’t be easily measured in the blood, or when the drug’s therapeutic effect is delivered locally to a particular organ, rather than systemically, through the bloodstream. In other instances, showing active ingredient sameness can be challenging when the drug product contains an active mixture of components and not a single active molecule," Gottlieb wrote Monday in a blog post.

Other New Generic Drug Guidance

Also on Monday, FDA released two other new draft guidance documents: One on refuse-to-receive standards for ANDA submissions and one on amendments to ANDAs under GDUFA II.

In terms of the one on amendments, GDUFA II simplified the amendment review goals and no longer subjects them to a tiered system. In general, GDUFA II amendments will be designated as either standard or priority, the draft guidance says, and will be classified as either major or minor (as defined in 2001 guidance), and receive a goal date based on certain factors, including whether a preapproval inspection is needed.

Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry

ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin

ANDA Submissions – Refuse-to-Receive Standards: Questions and Answers Guidance for Industry

ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA Guidance for Industry


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