Generics makers comment on draft ANDA guidance

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Sign up
eng / esp

Generics makers comment on draft ANDA guidance

Home/Guidelines | Posted 05/09/2014 0 Post your comment

The quality of abbreviated new drug application (ANDA) submissions could be improved if the US Food and Drug Administration (FDA) spent more time with generics companies before they file an application, according to the Generic Pharmaceutical Association (GPhA).

Commenting on a June 2014 draft guidance, the GPhA says that ANDA filers sometimes get comments from FDA reviewers on issues that could have been easily addressed beforehand. They are therefore calling for FDA to conduct pre-submission meetings with each ANDA applicant, as they do with brand-name manufacturers in the run-up to a new drug application (NDA).

The FDA guidance, which clarifies the content and format of ANDA submissions, received 15 comments from the GPhA and individual generics makers.

In addition to pre-submissions meetings, the GPhA urges FDA to expand the guidance’s current focus on oral dosage forms and sterile products to include other types of administration, such as complex dosage forms. This is a contentious issue because generics makers often do not have enough guidance on how to present data on complex dosage forms in their ANDAs, resulting in the FDA finding deficiencies after submission, the group says.

Mylan mirrored GPhA’s concerns about including other dosage forms like inhalation and transdermal systems. Sterility is not the only factor that should require additional information, according to Mylan, and the challenge of adapting to different dosage forms will only continue to increase across the generics industry.

Drugmakers also criticized parts of the guidance that call for redundant pieces of product testing data in multiple parts of each ANDA filing. Also pointing out that the draft calls for a table of contents in Module 3 of a filing even though the eCTD (Electronic Common Technical Document) recommendations specifically say not to include one.

Related Article
US guidelines for generics

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: US FDA, One Quality Standard