Changes to Come at CDER: A Letter From Janet Woodcock

Just received confirmation of last post.  Here's the official letter announcing changes from CDER Director, Dr. Janet Woodcock

FDA to Give Generics More Prominence: Rumors of Change

Haven't confirmed any of this yet, but just heard rumors of change, and another 'superoffice' restructuring at FDA. Apparently, within the new framework, the Office of Generic Drugs will become a "superoffice", OPS will be no more, while OMPQ, ONDQA and OBP will report to OPQ.  The Office of Compliance...

Pondering the Root Cause for, and Solutions to, Today's Drug Shortage Problem at BIO 2012

On Monday, June 18th, BIO 2012 was much more subdued than I’d remembered seeing it in the past.  However, it was just the first official day, and a number of breakout sessions touched on important topics. 

Death-penalty Drugs: Judge Chides FDA for Hypocrisy

Today, Ed Silverman of Pharmalot reviews the opinions of U.S. District Court Judge Richard Leon in a ruling that FDA to exercise appropriate authority over the importation of drugs used for death-row injections.

Not Pfizer? All the More Reason to Think Big about Securing the Supply Chain

One could say that supply chain security is the most critical issue facing drug manufacturers today—and perhaps facing our healthcare system as well. The supply chain is at the heart of healthcare’s greatest problems—drug counterfeiting and adulteration, shortages of key medicines, and of course escalating medical costs.

FDA Warning Letter to GSK Worthing: Prudent or Picky?

A few weeks ago, SmithKline Beecham’s Worthing West Sussex, U.K., site received an FDA warning letter related to, primarily, alleged failure to ensure microbiological contamination of products manufactured there. The site was inspected last March, and in April the Agency said that GSK's response to initial concerns lacked sufficient corrective actions.

Quality by Design: A Regulatory Initiative No More?

A speaker at last week’s AIChE annual meeting joked about the nitty-gritty, technical nature of the conference’s Quality by Design topical track. QbD talks at some shows are a bit like Las Vegas, he said—more superficial than substantial—whereas at AIChE they were “more like M.I.T.”

Behold the Master Matrix: How Risk-MaPP Works in the Real World

In September, FDA sent a warning letter to Sichuan Pharmaceutical Co., an API manufacturer in China. The letter cited the manufacturer's failure to adequately guard against potential product cross-contamination:

Save or Scrap Part 11? Gregor Weighs the Options

Earlier this summer, we wrote about a talk by FDA CDER’s George Smith, the lead for the Agency’s 21 CFR Part 11 working group, regarding the “add on” surveillance of computer systems that FDA is now performing during the course of its regular site inspections.

When Guidelines Need Guidance: ICH Releases “Points to Consider”

Over the past several years, the ICH Quality Implementation Working Group has helped to develop and spearhead the adoption of ICH Q8, Q9, and Q10, guidelines which spell out the Quality by Design principles that (slowly but surely) drug manufacturers worldwide are taking to heart.