FDA and the EMA (European Medicines Agency) Issue Q&A Document to Communicate Results from Initial QbD Parallel Assessment

On August 20, 2013, FDA and the EMA (European Medicines Agency) published a document entitled, “EMA-FDA pilot program for parallel assessment of Quality-by-Design applications: Lessons learnt and Q&A resulting from the first parallel assessment.”   The Q&A document provides information regarding agreements that were made between the agencies as a result of the first FDA-EMA parallel assessment that was conducted in a three year pilot program that began in March 2011. 

Acetaminophen Can Cause A Rare Serious Skin Reaction

In a safety communication late yesterday, the FDA warned the public about the potential for acetaminophen to cause a rare, potentially fatal skin condition called Stevens-Johnson Syndrome (SJS), toxic epidermal necrosis (TENS) and acute generalized exanthematous pustulosis (AGEP). The Agency discovered this through evaluation of the literature and a search of its Adverse Events Database.

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.

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.

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.

A Flair for the PLAIR

, what is a PLAIR? It stands for Pre-Launch Activities Importation Request. Over the last few years, the FDA had issued some informal directions in the form of an instructions sheet and a Question and Answers document. Today the contents of those documents have been incorporated into a Draft Guidance

Will My Satisfactory Inspection Status Expire Before My ANDA Is Approved??

The effective “expiry” of a satisfactory inspection and the need to re-inspect a facility before granting of ANDA approval has become a practical problem for the generic industry, which carries the risk of potentially significant consequences including marketing delays, loss of projected revenues and forfeiture of exclusivity entitlement in a worse-case scenario. In light of this continuing challenge, and in light of some existing ambiguities regarding FDA inspection policy, Lachman contacted CDER’s Office of Compliance to determine its current policy regarding conduct of inspections required in support of approval of ANDAs.

What is FDASIA?

The Food and Drug Administration Safety and Innovation Act, more commonly known as FDASIA, was signed into law on July 9, 2012 (Public Law 112-144) and has been getting increased publicity as the provisions in the Act are getting more action and traction.