Generics Makers Chime in on ANDA Filing Draft Guidance

August 20, 2014

To improve ANDA submissions, the FDA should spend more time with generics companies before they file an application, as is done with brand manufacturers in the run-up to an NDA, the Generic Pharmaceutical Association says.

Commenting on a June draft guidance, GPhA says that ANDA filers sometimes get pushback from FDA reviewers on issues that could be easily addressed beforehand, if the agency had the resources to conduct presubmission meetings with each applicant.

The guidance, which clarifies ANDA submissions requirements, received 15 comments from GPhA and individual generics makers.

In addition to presubmissions meetings, GPhA urges the 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.

The issue is troublesome because generics makers often don’t 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, Mylan says, 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. And the draft calls for a table of contents in Module 3 of a filing even though the eCTD recommendations specifically say not to include one, several commenters note. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.