Articles by Laura Bush - BioPharm International

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Articles by Laura Bush

What the Heparin Crisis Should Tell Us

Mar 1, 2008

The cause of the heparin crisis is still unknown. We do know, however, that the FDA is severely underfunded.

FDA Requests 5.7% Increase in 2009 Budget

Feb 12, 2008

The US FDA has requested nearly $2.4 billion for its fiscal 2009 budget, a 5.7% increase over the budget that FDA received for the current fiscal year.

Public Database for Extractables and Leachables Data Proposed

Feb 12, 2008

A public database of extractables and leachables data would save time, effort, and costs during drug development, agreed participants at the CMC Strategy Forum on Extractables and Leachables on January 27.

Inspections in a Global Industry

In our increasingly global industry; foreign manufacturing inspections are more important than ever.
Feb 1, 2008

In our increasingly global industry; foreign manufacturing inspections are more important than ever.

Satisfied, Well Paid, and Secure

BioPharm International's second annual salary survey confirms that the biopharmaceutical industry is a great place to work
Jan 1, 2008

Our second annual salary survey assesses not only how much people earn, but also how they feel about it.

It's the Intangibles that Matter

Jan 1, 2008

The number one source of job satisfaction? A sense of accomplishment from a job well done.

Taking a Closer Look

Dec 1, 2007

Many companies acknowledged that Western regulatory standards are tougher than those in China.

The Difficulty of Giving Things Up

Nov 1, 2007

The challenge is not in coming up with a list of activities to discard, but in finding a feasible way to stop doing them.

Quality by Design Pilot for Biotechs Will Focus on Comparability Protocols, Winkle Says

Oct 10, 2007

The upcoming Quality by Design (QbD) pilot program for biotech filings will focus on comparability protocols, Helen Winkle, director of the Office of Pharmaceutical Science at the FDA's Center for Drug Evaluation and Research, said on September 20, 2007.

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