Rethinking Biometrics Resourcing in Modern Clinical Trials
Rethinking biometrics as a strategic function to improve consistency, scalability, and clinical trial performance.
Project Management - 100% Responsibility and 0% Authority
Project Managers face a unique set of challenges every day. One of those that comes to mind often is how we, as Project Managers, succeed when we have 100% of the responsibility for the project...
Five Most Common Mistakes When Writing an Investigation
The most recent FDA report (FY2010) said the third highest reason a 483, warning letter, or consent decree was issued was because of discrepancies and/or failures in investigations due to inadequate...
Do you need a starting point for a Serialization User Requirement Spec (URS)?
One of the challenges to starting any User Requirement Specification (URS) is to envision a structure which can allow for traceability as the project continues. The attached sample URS is a starting...
Regulatory Sciences
Extended Review Timeline for Certain Applications under Proposed PDUFA V
The Prescription Drug User Fee Act (PDUFA) is due to be reauthorized by the end of September this year. Along with the usual increases in fees, the latest version of the act (PDUFA V) includes some...
Regulatory Sciences
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...
Regulatory Sciences
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....
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...
Regulatory Sciences
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...
Regulatory Sciences
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...
Regulatory Sciences
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...
Regulatory Sciences
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...
Regulatory Sciences
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...
