To Lead, You Need Followers

Erik Greb PharmTech editorThe wait may soon be over for US Food and Drug Administration employees wondering who their new boss will be. President Obama is expected to introduce Governor Kathleen Sebelius of Kansas today as his new nominee for secretary of the US Department of Health and Human Services. Read more »

Sunshine in 2009

Erik Greb PharmTech editorNow is the time when the ambitious among us decide how we’re going to improve ourselves during the new year. The pharmaceutical industry is starting 2009 with an effort to reassure the public that its interactions with doctors are on the up and up. Read more »

A Rule for Sam Spade

Erik Greb PharmTech editorWe’ve all seen unsuspecting movie characters laid low by poisoned drinks (as in “The Maltese Falcon”). Similar scenes were in my mind when I heard reports that trace levels of drugs had been found in American cities’ drinking water. That’s why I was happy to see that the Environmental Protection Agency (EPA) had begun to strengthen the regulation of discarded medicines. Read more »

Going Public: NIPTE’s New Design-Space Project

Maribel Rios PharmTech editorOver the years, I’ve heard several pharma industry members point out the catch-22 of seeking the advice of experts at agencies such as FDA and USP. These agencies hire some of the most well-respected experts in their field, however, when they are speaking as FDA or USP officials, they must be careful to stick to the agency script and may be somewhat restricted into providing only what has been “approved” to say. I’ve attended conferences in which the moderator will start off saying, “speaking as a (USP, FDA, etc.) officer, I can only say…” and so on. This may be necessary in front of a large audience, of course, but can also be a hurdle for real information sharing. Read more »

FDA: King of the Wild Frontier

Erik Greb PharmTech editorA lot of us (myself included) think of the Internet as a wild frontier where anything’s possible. It’s a place with no rules where journalists and researchers can publish considered opinions and bloggers can say outrageous things (myself excluded, of course). The Internet is a place where you have to use your own judgment because no one is monitoring the truth or accuracy of people’s claims.

Or so we thought. Read more »

FDA Seeks Science Power

Maribel Rios PharmTech editorAbout six years ago, I wrote an editorial describing my skepticism over FDA’s plans to incorporate more science into its regulatory oversight. At that time, the industry had just been introduced to the concepts of the new risk-based initiative, and Pharm Tech received regular inquiries about “this PAT we keep hearing about.” Companies complained that good science was being suppressed by strict adherence to traditional processing and analytical methods. “Alternative” methods were definately discouraged, even if it was well known that the technologies were more efficient. I had my doubts about the agency’s promises to let good science lead the lead to greater regulatory flexibility. Now I’m happy to eat my words. Read more »

Large-Scale QbD

Maribel Rios PharmTech editorFDA is on its way of getting a boost to its 2009 budget for strengthening its drug-import safety program. Earlier this week, HHS Secretary Leavitt asked Congress for an additional $100 million to improve international safety points, from preapproval testing to postapproval surveillance. Read more »

Should Globalization Act Include Online Distribution?

Maribel Rios PharmTech editorReviewing the draft Food and Drug Administration Globalization Act, I agree with the testimony of Biotechnology Industry Organization President and CEO Jim Greenwood last week to the House Engergy and Commerce Subcommittee on Health: “this ‘closed’ system for imported drugs and drug products is an essential element in ensuring drug safety in the US. Efforts to broaden importation of drugs will undermine efforts to strengthen the system and add to the FDA’s already heavy burden.”

I wonder, however, whether during the development of this act there was sufficient consideration into expanding authorization (to FDA?) to monitor online vendors and distributors. Read more »

PAT and QbD Have Many Benefits, but Don’t Bank on Regulatory Relief

drakulich.jpgBrian Stephens, a life sciences consultant for ABB INC, addressed the Interphex 2008 attendees this morning in a discussion about process analytical technology (PAT). He threw out the “learn, predict, control” phrase industry has latched onto as an easier way to define PAT, which is essentially a tool or system for implementing QbD that involves identifying critical quality attributes (CQAs) and critical process parameters (CPPs), and then figuring out the best way to measure the CQAs in order to control the CPPs.

Stephens went on to describe how some 60 FDA investigators are undergoing PAT training this year so they can be better prepared for inspections (and ideally avoid a repeat of the validation inspection process of the 1980s and early 1990s when computer validation came into play). (I find it quite strange, by the way, that FDA has been rolling out and pushing PAT initiatives while still learning about it themselves. Seems like the order of things here is somewhat backward.) Read more »

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