Pharmaceutical Technology-08-02-2006

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.

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%.

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.

After years of discussion and work, FDA has made the structural changes that will make the new regulatory and manufacturing concepts an everyday reality.

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.

Thanks to you, we have this month's column. Keep those cards, letters, and e-mails coming.

Combinatorial catalysis in asymmetric synthesis and asymmetric biaryl Suzuki coupling highlight recent advances in chiral chemistry. Plus the marriage of green and chiral chemistry.

Returnees and home-grown talent aim to make China a pharmaceutical powerhouse.

Ranbaxy issued three responses (March 20, April 20, May 25) to FDA's Form 483.

Contract service providers should be concerned about the market perceptions of their performance.

The new drug user-fee program will define how FDA does business over its next 100 years.

How does the latest agency task force report resonate for pharma and radio-frequency identification?