Wait a Minute – Did Everyone Think This One Through?

Oftentimes, over the years when I was working at the FDA, policy decisions were made way above my pay grade that did not really have buy-in from us program folks.  In my further review of the FDA’s Draft Q&A Guidance on the implementation of the new stability requirements, I wondered if program and policy were singing the same tune on the issue of amendments (and supplements) to abbreviated new drug applications (ANDAs) submitted prior to the June 20,

Compounding Pharmacies – Do You Notice a Trend Developing?

Ever since the meningitis outbreak associated with the products from the New England Compounding Center, the FDA and the States have been taking a closer look at this segment of the industry. So far, in 2013 alone, the FDA has issued 51 Safety Alerts for Human Medical Products, of which 17 (33%) related to sterile pharmacy compounded products and/or laboratories that tested those products for sterility and/or potency. In addition, FDA has taken 54 separate actions against compounding pharmacies in 2013 alone, with only 24 actions taken in the previous 5 years.

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