Equipped with a new sourcing strategy in Asia and improving market conditions, Pfizer CentreSource expects a good performance from its steroid business this year and in 2008.

The US Food and Drug Administration launched a new program on Oct. 4 to increase the number and variety of generic drugs available to the public, beginning in fiscal year 2008. The Generic Initiative for Value and Efficiency (GIVE) will use existing resources to help the agency "modernize and streamline the generic drug approval process," according to FDA.

Representatives from 17 nations sit down to decide upon standards-setting initiatives.

As the mother of a 15-month-old, I was quite shaken last month to hear about over-the-counter cold medicines for children under age 2 being pulled off the shelves. Glued to the news, I wondered if the decongestant I had given my daughter when she was sick would have any negative impact on her long-term health.

News and Views

Thin are the lines that separate stability, statistics, and chaos.

Thanks to the media, Nobel Laureates are underrated, undervalued, and simply uncool.

The EIP process addresses the problems encountered with numerous questionnaires when qualifying excipient manufacturers.

Some people claim the statins are so effective and that their cholesterol has dropped to a point where they can "supersize" their burger and chips every time they visit a fast food outlet

Company Notes: Gibraltar expands facilities; Allozyne appoints new president and CEO, more.

The US Food and Drug Administration announced the formation of the Pediatric Review Committee to help ensure quality and consistency across the agency.

In accordance with the US Food and Drug Administration Amendments Act of 2007, FDA is asking companies to notify the agency within 30 days whether they intend to participate in FDA?s direct-to-consumer user-fee program during fiscal year 2008.

The pharmaceutical market is undergoing a major transformation with companies moving more and more toward the generics business, according to a new report.

After a whirlwind of negative press this fall regarding the safety of cough and cold medications for children under age 6, the US Food and Drug Administration?s Nonprescription Drugs and Pediatric Advisory Committees have recommended such over-the-counter drugs no longer be used for young children.

Company and People Notes: ImClone, BMS, and Merck form agreement; CRI Worldwide names new CEO, more.

Medical students are participating in various activities this week to persuade medical schools to shield their campuses from the influence of pharmaceutical marketing as part of ?National PharmFree Week.?

Under a new US Food and Drug Administration revision, sole manufacturers of drugs considered life-supporting, life-sustaining, or for prevention of certain serious diseases or conditions will be required to notify FDA at least six months before discontinuing production of the product.

On behalf of manufacturers of over-the-counter (OTC) infant cough and cold medications, the Consumer Healthcare Products Association announced a voluntary withdrawal of products intended for use in children under age 2.

The US Food and Drug Administration posted its rates for user fees for fiscal year 2008, effective Oct. 1, 2007 through Sept. 30, 2008.

The US Food and Drug Administration sent Med-South Pharmacy a Warning Letter for producing large volumes of betamethasone acetate?betamethasone sodium phosphate without following current good manufacturing practices (CGMPs).

Company and People Notes: Orexo acquires Biolipox, Avalon cofounder resigns, more...

Pfizer decided to stop investing in ?Exubera? (inhaled insulin), a product that had been considered a potential blockbuster drug.

GlaxoSmithKline and Synta Pharmaceuticals agreed to jointly develop and commercialize STA-4783. The drug is an injectable, small-molecule, oxidative stress inducer for treating metastatic melanoma that is entering Phase III clinical development.

CPhI Worldwide, the large trade show of suppliers of active pharmaceutical ingredients (APIs), intermediates, and excipients, took on a decidedly international presence.

The US Food and Drug Adminstration?s Center for Biologics Evaluation and Research has issued a Warning Letter to Genzyme Corporation.

Company and People Notes: Novartis and MIT to study continuous processing, GSK appoints Andrew Witty as CEO, more.

The US Food and Drug Administration will hold a public meeting on November 14, 2007 to solicit comments about the proposed behind-the-counter (BTC) availability of drugs.

The European Fine Chemicals Group (EFCG) issued a position paper on excipients used in pharmaceutical manufacturing at CPhI Worldwide last week.