Is Part 11 Dead? Part 1 of a series– Electronic Records

Hardly!  But Part 11 (21 CFR Part 11), which applies to records in electronic form and the use of electronic signatures required by predicate rule (i.e., those records required to be signed by GMP regulations), has been scrutinized and discussed among regulators and the industry over the years, and the industry is still waiting on the final revised ruling.

The MaPP to Nowhere!

For those of you who have not yet read MaPP 5200.3 (here).   Responding to Industry Inquiries with Respect to Abbreviated New Drug Application in the Office of Generic Drugs, you better have your CEOs take a Valium prior to your reporting its contents.  In a nutshell, it says you can call us – but only the Regulatory Project Manager (RPM) and the call must be from your single designated industry contact,

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.

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.