Increased investment by the pharmaceutical and biotechnology majors in offshore early drug development creates opportunities and challenges for outsourcing.

Congress is considering proposing a new chemical policy similar to the European Union’s REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation. Batch and custom manufacturers weigh in on the debate.

Congressional hearings were held last week on the Food and Drug Administration Globalization Act discussion draft.

The European community and European Federation of Pharmaceutical Industries and Associations (EFPIA) held its first call for proposals for its five-year, €2 billion ($3.1 billion) initiative to boost biomedical innovation.

Also, FDA removes OAI status for Watson's Florida facility, executive management changes as GSK, more...

Polyplus-transfection, a company that researches, develops, and commercializes drug-delivery solutions for biomolecules, created a new technology designed to enhance in vivo delivery of small interfering RNAs (siRNAs) when they are associated with a cationic polymer.

To keep pace with proposed increases in the number of manufacturing inspections, the US Food and Drug Administration's Office of Regulatory Affairs (ORA) has announced it will increase laboratory capacity and staff.

Merck and Company?s West Point, Pennsylvania facility received a Warning Letter from the US Food and Drug Administration.

Scientists are giving up on a preventive vaccine for AIDS, but there are lessons to be learned.

Getting IT, engineering, and manufacturing on the same page requires a delicate balance.

Florida is making its case for pharmaceutical and biotechnology research and development.

An authoritative book helps drug developers face one of their toughest problems.

The less complex nature of excipient manufacturers, as compared with API manufactures, carries many benefits.

Brief pharmaceutical news items for May 2008.

WFI system deficiencies and damp tax records cause problems for two plants

According to the latest figures from IMS Health, Inc., Japan's pharmaceutical market is expected to grow 1–2% this year compared to global industry growth expectations of 5–6%.

One of the headlines before going to print was 'Pfizer earnings suffer as patent expiries cause damage'. This US pharma giant has reported a net income decline of 18% for the first quarter, despite the positive impact of the favourable currency rates.

Congress is taking on the issue of inspection of foreign drug-manufacturing facilities as it began hearings on a discussion draft of the Food and Drug Administration Act of 2008.

US Food and Drug Administration leaders issued another cry for help last week. Center for Drug Evaluation and Research Director Janet Woodcock testified before the Senate Health, Education, Labor and Pensions (HELP) committee at an April 24 hearing, "Restoring FDA's Ability to Keep America's Families Safe."

Also, Genzyme to build R&D center in Beijing, Noven Pharmaceuticals appoints Peter C. Brandt president and CEO, more...

Problems associated with contamination of heparin products continue after worldwide recalls in March in the United States, Italy, France, and Denmark.

Researchers from the Georgia Institute of Technology described a fast method to detect counterfeit "Tamiflu," Roche's drug for preventing and treating bird flu.

The United States Pharmacopeial Convention (USP) has agreed to work with the US Food and Drug Administration on developing more sensitive tests for detecting contaminants such as over-sulfated chondroitin, which was found in batches of heparin last January.

The US House of Representatives Energy and Commerce Committee is proposing legislation to address the funding and authority of the US Food and Drug Administration in regulating the safety of the country's drug supply.

Ell Lilly plans to streamline a portion of its manufacturing operations in Indianapolis.

The US Food and Drug Administration issued a draft guidance to clarify the Agency's intensions stated in the Food and Drug Administration Amendments Act of 2007 (FDAAA) requiring sponsors, industry, researchers, and investigators to complete certification form FDA Form 3674 when submitting documentation to the Agency in order to comply with FDAAA, Title VIII.

Also, GSK expands in Ireland, executive appointments at ProGenTech, more...

The US Food and Drug Administration appointed Frank M. Torti, M.D., M.P.H, as principal deputy commissioner and chief scientist. Torti's appointment with FDA will begin in May.