Stuck on you – Now in Technicolor

Today, the FDA announced a change in labeling requirements for all Fentanyl Transdermal Systems in an effort to prevent inadvertent overdose. FDA is also warning patients and caregivers to dispose of patches properly, and warning that patches that do not adhere properly to the patient might fall off and accidentally adhere to another person, such as a child or a caregiver, or even a pet, and, based on the amount of drug left in the patch (should this occur), could cause death!

This Road Has Been Traveled Before? Chance of Success Approaching Zero!

IntelGenx Corporation of Saint Laurent, Quebec, Canada submitted petition FDA-2013-P-1058 (here) on August 22, 2013, asking the FDA to designate its Rizatriptan Oral Film product as AB rated (or therapeutically equivalent [TE]) when approved to Maxalt-MLT Orally Disintegrating Tablets, the reference listed drug (RLD) cited in its 505(b)(2) application. The fact that the two products might perform similarly does not overcome the fact that the products are different dosage forms.

Reporting of Serious Adverse Events for Dietary Supplements and OTC Drugs – A Simple Idea

Since December 22, 2007, the Dietary Supplement and Nonprescription Drug Consumer Protection Act has required that serious adverse event information be reported to FDA for dietary supplements and OTC drugs not approved through a new drug application. There are many questions that can come up as soon as you dig a little deeper into what is required. Some answers will be provided here, but these are meant only to call attention to the potential complexity and depth of these requirements.

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.