The Lachman Blog

02
Aug

GDUFA Fees Rise – While Generic Firms are Getting Restless

FDA announced the Fiscal Year 2014 User Fees to begin on October 1, 2013. This rise in fees was expected since the number of ANDA projected to be submitted in 2013 appears as if it may drop below the 1103 submitted in 2012. In addition, the number of facilities self-identifying was slightly lower than anticipated. Also remember that, in year one of GDUFA, there was $50 million of the $299 million permitted for 2013 associated with backlog fees to address the logjam of ANDAs in the backlog. That was a one- time fee which must now be made up by increases in the ongoing yearly fees.

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30
Jul

FDA-Mandated Label Changes Guidance Gives Insight to Potential ANDA Applicants Requirements to Seek Label Changes

FDA published its final Guidance to Industry – Safety Labeling Changes – Implementation of Section 505(o)(4) of the FD&C Act on July 30, 2013. Section 505(o)(4) (enacted under the FDAAA in 2007) gave the FDA new authority to require NDA, BLA and ANDA applicants for which there is no corresponding NDA to make certain label changes if there is new information available relative to safety issues. That new safety information may impact or require a Boxed Warning, changes to the Contraindications, Adverse Event or Warnings sections of the labeling. It could also require a change to a REMS program or patient information sheet.

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25
Jul

Turtles Get A Reprieve!

In a Federal Register Notice to publish today, the FDA is issuing a direct Final Rule that eliminates the destruction of certain turtle eggs and turtles less than 4 inches by or under the supervision of an FDA investigator (see FR notice here).
The original regulation with was designed to stop the spread of turtle-related salmonellosis (particularly to children) banned the sale or possession of certain turtle eggs or live turtles with a carapace length of less than 4 inches.

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