As part of the PDUFA V reauthorization discussions, the FDA and industry are talking about better approaches to rare disease drug development and orphan drugs. Public interests and Congress have mandated that FDA develop new guidances on the required studies needed for NDA approval. In these discussions, participants refer to the “pediatric drug development approach” [...]
Archive for March, 2011
What is the Pediatric Drug Development Approach for Rare Diseases and Orphan Drugs?
Published March 23rd, 2011 in 505(b)(2) Issues and News Commentary. 0 CommentsUser Fee Waivers: What is an Affiliate? New Guidance Issued
Published March 10th, 2011 in How to:. 0 CommentsUnder the current PDUFA regulations, a small business can request a waiver of the normal review fees for an NDA if it is the first NDA submitted by the small business. The definition of a small business is fewer than 500 employees. In determining the 500 employee limit FDA also considers the affiliates of the [...]
Revised Safety Reporting for BE/BA Studies Effective March 28, 2011
Published March 23rd, 2011 in News Commentary. 0 CommentsOn September 29, 2010 FDA published a Final Rule revising the requirements for safety reporting for INDs and other BE/BA studies. At the same time FDA issued an accompanying draft guidance to assist in interpreting the new rule. The Final Rule, revising 21 CFR §§ 312.32, 312.64 and 320.31, becomes effective March 28, 2011. The [...]