When to Submit an ANDA vs. a 505(b)(2) Application: FDA Discusses in Draft Guidance
By Zachary Brennan -
Published 12 October 2017
The US Food and Drug Administration (FDA) offers multiple abbreviated approval pathways for potential drug developers, and in new draft guidance released on Thursday the agency explains both the pathways where abbreviated new drug applications (ANDAs) and 505(b)(2) applications can be submitted.
Categories: News, US, CDER, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy
Tags: 505(b)(2) application, ANDA, FDA draft guidance
FDA Cracking Down on Attempts to Delay Entry of Generic Drugs, Data Show
By Alexander Gaffney, RAC -
Published 18 November 2014
A new report issued by the US Food and Drug Administration (FDA) on the use of petitions meant to delay or prevent the entry of new generic drugs shows that the agency is denying those petitions in record numbers, even as regulators say its authority to dispose of them more easily is lacking.
Categories: News, US, CDER, Generic drugs, Regulatory strategy, Submission and registration
Tags: ANDA, Abbreviated New Drug Application, 505(b)(2) Application, 505(q) Petition, Citizen Petition