FDA updates guidance to clarify ANDA and 505(b)(2) approval pathways

The FDA released a draft guidance that updates a seven-year-old document on abbreviated drug approval pathways.

The guidance clarifies the distinction between traditional Abbreviated New Drug Applications under section 505(j) and the 505(b)(2) pathway, specifying the types of data the agency will consider for each.

The agency says the clarification should give sponsors clearer expectations and may help streamline the review of generic and hybrid products.