With the right technology tools, the sponsor organization and the contract manufacturer can have self-service, on-demand, and scheduled access to all manufacturing, quality, and process-development data.

The US Food and Drug Administration announced last week that it will be "conducting a series of inspections in an effort to evaluate industry's compliance and understanding of [21 CFR] Part 11."

Xcelience and Penn Form Joint Venture; Almac Appoints QA Director; And More.

States can reduce their Medicaid programs' healthcare expenditures by changing laws to enable generic drugs to be substituted for branded medications more easily and quickly, according to a new study conducted by CVS Caremark, a large pharmacy healthcare provider.

McNeil Consumer Healthcare, a division of Johnson & Johnson (J&J), has once again expanded the recall of certain OTC products because of a musty or moldy odor, which has been linked to trace amounts of the chemical 2,4,6 triburomoanisole (TBA).

The Laboratory Services Division of the Philippine Food and Drug Administration (FDA) has attained internationally recognized accreditation for its testing and calibration laboratories, according to a July 12, US Pharmacopeia (USP) announcement.

Merck & Co. (Whitehouse Station, NJ) released details of a restructuring plan last week, which calls for phasing out operations at eight research sites and eight manufacturing sites, resulting in a 15% reduction of its global workforce.

The Council of Europe (CoE) is hoping its Medicrime treaty can help curb the lucrative global trade in fake medicines.

The Pharmaceutical Research and Manufacturers of America (PhRMA) announced earlier this week that John J. Castellani will replace Billy Tauzin as President and Chief Executive Officer.

Changes to Part 2 of the EU GMP guide will come into force by 31 July 2010 in order to bring it in line with the ICH Q9 guideline on Quality Risk Management. As a result, it will no longer be identical to the ICH Q7 guideline on APIs - a harmonised guideline for the US, Europe and Japan.

Eli Lilly has made a move into enzyme replacement therapy by acquiring Alnara Pharmaceuticals, whose pancreatic enzyme replacement therapy, liprotamase, is currently under review by the FDA for the treatment of exocrine pancreatic insufficiency.

Last week, Senator Charles Grassley (R-IA) sent letters to 16 drugmakers, including Pfizer (New York), AstraZeneca (London), and Eli Lilly (Indianapolis), asking them about their current policies regarding whistleblowers?employees who file complaints under the False Claims Act (FCA).

The US House of Representatives passed on July 1, 2010, HR 4899, the Supplemental Appropriations Act of 2010, which included provisions restricting patent settlements between innovator-drug and generic-drug companies, a move that drew criticism from both sectors of the pharmaceutical industry.

Ethics Group Calls on FTC to Investigate Drug Pricing

Eli Lilly to Acquire Alnara Pharmaceuticals; Exelixis CEO Leaves for Biogen Idec; And More.

A roundup of developments on corporate social responsibility from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

Led by sustainability efforts by Walmart, a new tool emerges for quickly evaluating the environmental and human-health profile of formulated products.

Acumen Fund, a nonprofit venture-capital fund, uses patient capital to build economically sustainable businesses involved in poverty alleviation.

Duke University researchers have found a possible alternative to lyophilization.

The merger Novartis has been trying to unilaterally impose on Alcon cannot go ahead without the approval of Alcon's Independent Director Committee (IDC), according to a legal expert, and at the moment the IDC still believes that Novartis's offer is vastly inadequate.

To continue innovating, the biopharmaceutical sector needs support from all levels.

As generic divisions become the most-wanted acquisitions of Big Pharma, India's domestic industry may be thinning out.

Reports of overlooked controls, dropped pallets, and misplaced documents leave a chill in the air.

After a spate of industrial disasters, the public seeks greater oversight of corporations-so does FDA.

Pfizer Suspends Tanezumab Program; Actavis Appoints CEO; And More.

The US Food and Drug Administration's website now features a free online 90-minute training program on the "Past, Present, and Future of FDA Human Drug Regulation."

The US Food and Drug Administration issued on June 25 a draft guidance for industry, "CMC Postapproval Manufacturing Changes Reportable in Annual Reports," to provide recommendations to drug applicants about the types of changes that may be included in annual reports.

The Office of the Inspector General for the Department of Health and Human Services (HHS) issued a report, Challenges to FDA's Ability to Monitor and Inspect Foreign Clinical Trials, which evaluates the incidence of foreign clinical trials, the ability of the US Food and Drug Administration to oversee these trials, and recommendations to FDA on how to improve its oversight of foreign clinical trials.