The Food & Drug Administration is looking for input on its plans to expedite the approvals process for some biologic products.
The federal watchdog agency scheduled a two-day public hearing for Nov. 2-3 in Silver Spring, Md., to discuss the implementation of the Biologics Price Competition and Innovation Act of 2009.
That measure created an "abbreviated approval pathway" for biological products that are highly similar to, or interchangeable with, an FDA-licensed biological product, according to a press release.
"The purpose of the hearing is to receive input on the act’s implementation from the public, health care professionals, health care institutions, manufacturers of biomedical products, industry and professional associations, patients and patient associations, third party payers, and current and prospective biological license application and new drug application holders," according to the release.
