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Pharmaceutical Technology-08-02-2006
Pharmaceutical Technology
Schering Recalls Ultravist Injection
August 02, 2006
News
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8
Schering AG (Berlin, Germany) voluntarily issued a worldwide recall of all lots of its X-ray contrast agent "Ultravist Injection" 370 mgI/mL (iopromide injection) because particulate matter and crystallization may be present in the product.
FDA Boosts User Fees 17-19% for FY 2007
August 02, 2006
News
30
8
The US Food and Drug Administration announced its Prescription Drug User Fee Amendments of 2002 (PDUFA II) fees schedule for fiscal year 2007 (Oct. 1, 2006 - Sept. 30, 2007), including increases ranging from 17% to 19%.
The Modern Soapbox
August 02, 2006
This Time Around
30
8
Street-corner oratory may seem like a dying art, but if there's one place you can still find people literally up on their soapboxes, spewing views on religion, politics, or ethics, it's New York City. And, if there's one time I religiously follow the advice of my native New Yorker father ("Look down while you're walking and don't make eye contact with people you pass"), it's when I see these soapbox stars and the crowds surrounding them.
Reinventing FDA: A Mid-Course Report
August 02, 2006
Articles
30
8
After years of discussion and work, FDA has made the structural changes that will make the new regulatory and manufacturing concepts an everyday reality.
Cracking Down on Counterfeiting
August 02, 2006
Articles
30
8
Disappointed in progress thus far, the US Food and Drug Administration wants pharmaceutical manufacturers to make a greater effort to combat counterfeit products and recommends that they "move quickly" to implement radio-frequency identification technology.
Our Readers Write In
August 02, 2006
Agent-In-Place
30
8
Thanks to you, we have this month's column. Keep those cards, letters, and e-mails coming.
Rolling Out Advances in Chiral Chemistry
August 02, 2006
Articles
30
8
Combinatorial catalysis in asymmetric synthesis and asymmetric biaryl Suzuki coupling highlight recent advances in chiral chemistry. Plus the marriage of green and chiral chemistry.
China Just Around the Corner
August 02, 2006
From The Editor
30
8
Returnees and home-grown talent aim to make China a pharmaceutical powerhouse.
August 2006
August 02, 2006
In the Field
30
8
Ranbaxy issued three responses (March 20, April 20, May 25) to FDA's Form 483.
Is "Satisfactory" Contractor Performance Good Enough?
August 02, 2006
Outsourcing
30
8
Contract service providers should be concerned about the market perceptions of their performance.
FDA Marks 100 Years of Drug Manufacturing Oversight
August 02, 2006
Washington Report
30
8
The new drug user-fee program will define how FDA does business over its next 100 years.
FDA Is Taking Baby Steps Toward an RFID Mandate
August 02, 2006
Viewpoint
30
8
How does the latest agency task force report resonate for pharma and radio-frequency identification?