As a result of the passage of the Generic Drug User Fee Amendments Act, Janet Woodcock, director of the Center for Drug Evaluation and Research, announced her plan to reorganize the Office of Generic Drugs (OGD) into a super office that would include subordinate offices. The new super office would report directly to Director Woodcock, with Greg Geba continuing his role as OGD director.

Eli Lilly has received an FDA Warning Letter because of a "misleading" image of a multicolored brain that appeared on the company's website for the diagnostic PET tracer, Amyvid.

John Castellani, President of PhRMA, talks to PharmTech about its 2012 Research and Hope Award recipients.

Lilly Stops Phase III Development of Pomaglumetad Methionil; Hospira to Acquire API Manufacturing and R&D Facilities; and More.

A look at PharmaCheck, a field-based tool in development that uses microfluidic chip technology for assessing the quality of medicine in the developing world.

USP Hosts Symposium on Science and Standards

Merck KGaA has announced plans to eliminate 1100 jobs in Germany by the end of 2015—almost 10% of the company's 10,900 German positions.

A roundup of the latest developments for drug delivery of parenteral drugs.

A roundup of developments in corporate social responsibility (CSR) and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

The European Medicines Agency has launched a public consultation concerning its inventory of pediatric medicines with the aim of highlighting where further R&D efforts are required. The consultation is the first of its kind in this area.

Q&A on GDUFA implementation with Aloka Srinivasan, PhD, a principal consultant with Parexel and former team leader in FDA's Office of Generic Drugs.

PDA's strategic plan calls for maintaining valuable and effective relationships with global regulators.

Ties between the biotechnology industry and university research are crucial.

International trade can be great for business, but breaking border laws can put one in hot water.

Identifying and classifying rouge can help to determine CAPA.

USP optimizes identification tests and impurities procedures.

Brazil takes first steps towards gaining quality requirements for pharmaceutical excipients.

Regulators in both the EU and the US have attempted to stimulate paediatric-drug development with incentives offering extended periods of patent protection, but are these actions having the desired effects?

Policymakers must balance fundamental issues involving access to medicines and pricing.

The Johnson & Johnson subsidiary Janssen Pharmaceuticals has announced a settlement and consent decree with 36 states and the District of Columbia in regards to previously disclosed allegations related to the company's marketing and promotional practices relating to Risperdal (risperidone).

AstraZeneca Names Pascal Soriot CEO; The Merck Group Agrees to Acquire Biochrom; and More.

The Observational Medical Outcomes Partnership (OMOP), which is managed by the Foundation, desires feedback on proposed research priorities and tasks.

The European Medicines Agency has recommended that the anticancer medicine DepoCyte be recalled from EU countries following the discovery of manufacturing deficiencies at Pacira Pharmaceuticals' San Diego site.

Pfizer and Mylan have agreed to establish an exclusive long-term collaboration to develop, manufacture, distribute, and market generic drugs in Japan. The products included in the collaboration are expected to be sold under the Pfizer brand with joint labeling.

FDA Extends Pfizer's Action Date for Tofacitinib NDA; United Drug to Acquire Bilcare GCS; and More.

Eli Lilly has received $1.3 billion for payment of financial obligations from Amylin Pharmaceuticals following Bristol-Myers Squibb's acquisition of Amylin Pharmaceuticals earlier this month.

Myriad Genetics reported that a US federal appeals court has ruled that the company's composition of matter claims covering isolated DNA of the BRCA 1 and BRCA 2 genes are patent-eligible material under federal patent law. The court, however, denied the company's effort to patent methods of "comparing" or "analyzing" DNA sequences.

GlaxoSmithKline (GSK) is selling the majority of its 'classic brands' in Australia to Aspen Global for approximately £172 million ($271.1 million) in cash.