General Regulatory

Label Changes Related to the QTc Interval

In a recent FDA Drug Safety Communication, the Agency announced that the Celexa (citalopram hydrobromide) label now has revised dosing recommendations based on evaluations of post-marketing reports...

FDA Study Finds Lower Risk of Lung Cancer Among Menthol Smokers

In March 2011, the Tobacco Products Scientific Advisory Committee released a report on the impact of menthol on public health. Based on the committee’s review of all available evidence, they...

Cetero FDA Action

If your company has used Cetero Research's Houston facility to conduct bioanalytical studies between April 1, 2005 and June 15, 2010, your marketing applications may need to be repeated or confirmed....

Woman typing on laptop in an laboratory

Regulatory Sciences

GRAS List Substances: Background and Misconceptions

Although it is widely known that the acronym GRAS stands for “Generally Recognized as Safe”, many individuals believe that GRAS substances have been rigorously reviewed for safety and approved for...

You Do Have a Voice – The FDA Rulemaking Process

Did you know that the FDA Rulemaking Process allows for the public to comment before procedural and scientific requirements go into effect? This is the case for both the debut and amendments to...

FDA Shelf Life Extension Program (SLEP)

The FDA’s homepage contains an item in the Public Health Focus section from the Office of Communications entitled “Don’t Use Expired Medicine.” Given this mandate, I recall from many years ago the...

Food and Cosmetic Ingredients that are also Excipients in Drug Products – OGD Policy

In a recent teleconference with senior officials in the Office of Generic Drugs (OGD) at the FDA, it was conveyed that it is the policy of OGD in determining the safety of excipients to rely...

Innovation vs. Safety: Another Definition for the “Chicken or the Egg”

We all know that the FDA’s mission is to promote and protect public health. However, in their effort to protect the public health, it seems that they may be inadvertently harming the industry that...

Citing the IIG as Evidence of Ingredient Safety Comes with Caveats

It has become common practice in developing drug formulations to consult the FDA's Inactive Ingredient Guide (IIG) to obtain information on "acceptable levels" of excipients used in previously...

Competition Between Orphan Drug Sponsors – Good for Patients, Strategic Complexities for Sponsors

The regulations developed by the FDA for implementing the Orphan Drug Act contain a number of features that are intended to maximize benefits to the orphan disease patient population, but which pose...