John Dingell (D-MI), chairman of the US House Committee on Energy and Commerce and Bart Stupak (D-MI), chairman of that committee's Subcomittee on Oversight and Investigations, directed a letter to US Food and Drug Administration Commissioner Andrew C. von Eschenbach to request further information regarding FDA's process for inspecting manufacturing facilities of the generic drug manufacturer Actavis following several product recalls by the company.

The lack of appropriate financial resources for the US Food and Drug Administration's growing global agenda has been a pertinent topic of late?and now appropriate staffing has become a large concern.

Integrating MES with enterprise resource planning (ERP) systems can bring companies greater control over production than before and make manufacturing processes more flexible.

A bill that would require country-of-origin labeling for active and inactive ingredients for all prescription and over-the-counter pharmaceuticals was introduced in the US Senate last week.

The US Food and Drug Administration?s Center for Drug Evaluation and Research (CDER) held a public meeting on Oct. 2 to discuss over-the-counter (OTC) cough and cold medications for pediatric use.

Under a definitive merger agreement, Eli Lilly and Company will acquire ImClone Systems, Inc. (New York) in a cash tender offer of approximately $6.5 billion.

Rep. John D. Dingell (D-MI), chairman of the US House of Representatives Committee on Energy and Commerce, and Rep. Bart Stupak (D-MI), the chairman of the Oversight and Investigations Subcommittee, sent a letter to the US Department of Health and Human Services (HHS), questioning the US Food and Drug Administration?s use of agency resources to hire an outside public-relations firm to create a positive public image of the agency.

The electronic pedigree mandate for prescription drugs has been delayed again. California Gov. Arnold Schwarzenegger signed legislation that delays ePedigree implementation until 2015.

Also, Merck & Co. discontinues development of its obesity drug taranabant; Synthetech names Frederic Farkas director of manufacturing; more...

Buoyed by increased demand for pharmaceutical outsourcing services, Ricerca Biosciences proceeds with an expansion plan.

The pharmaceutical industry faces compliance with the REACH regulation, the European Union's regulation on chemicals and their safe use. Fully understanding the requirements, achieving compliance, and developing strategies for working with suppliers are key for avoiding interruption of the supply chain.

Pharmaceutical companies want software vendors to make integrating manufacturing execution systems and enterprise resource planning systems easier.

Industry needs a standard to connect systems and equipment sooner rather than later.

A recent report shows a decline in NASs and a rise in NME applications in 2007.

Planning ahead will ensure successful efforts to improve packaging and packaging operations.

Brief pharmaceutical news items for October 2008.

To err may be human, but to really mess things up, you need management.

Although the European Union's approval rates of biosimilars for market is increasing slower than expected, its approach may provide an example for other foreign markets.

Can previous trends of Democratic and Republican administrations predict industry's future?

A book offers a detailed introduction to the new area of risk evaluation and mitigation strategies.

A public meeting is being held today to discuss over-the-counter cough and cold medications for pediatric use.

Also, Alpharma advises shareholders to reject King's offer; ImClone rejects raised BMS offer; Immunogen appoints Daniel M. Junius, more...

The International Electrotechnical Commission (IEC) has approved HART 7.1, the WirelessHART Communication Specification, as a Publicly Available Specification (IEC/PAS 62591Ed.1). WirelessHART is the first industrial wireless communication technology to achieve this level of approval.

Eli Lilly and Company plans to launch an online registry of its payments to physicians in 2009.

SAFC, Regis Technologies, Carbogen Amcis, Cambridge Major Laboratories, and AMRI are among the companies at CPhI Worldwide in Frankfurt this week that are moving forward with expansions.

Ionic liquids provide an alternative to certain solvents in select reactions used to synthesize intermediates and active pharmaceutical ingredients.

Counterfeiting has become the topic of conversation at all levels of the pharmaceutical industry. Considering the rising number of cases, this is hardly surprising.

Also, Zentiva accepts Sanofi's increased takeover bid, Oriel Therapeutics appoints Richard Fuller CEO, more...