FDA发布ANDA相关的四个指南文件（2017.10.02）

beiwei5du · 发表于 2017-10-3 18:08:33

欢迎您注册蒲公英

您需要登录才可以下载或查看，没有帐号？立即注册

x

本帖最后由 beiwei5du 于 2017-10-3 18:10 编辑

FDA Publishes ANDA Guidance Documents

The agency published four guidance documents regarding ANDAs and amendments to ANDAs.
Oct 02, 2017

By Pharmaceutical Technology Editors

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

beiwei5du · 发表于 2017-10-3 18:22:24

FDA Targets Complex Generic Drugs With New Draft Guidance
Posted 02 October 2017By 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(FDA) on Monday kicked off a two-day meeting on modernizing generic drug development and released two new draft guidance documents on complex generic drugs – an area where increasing competition can be difficult.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

选自：http://www.raps.org/Regulatory-F ... New-Draft-Guidance/