The European Commission has released a concept paper for public consultation that provides details about implementing pharmacovigilance measures, which will be necessary as part of the Commission's 2010 amended pharmacovigilance legislation.

The International Society for Pharmaceutical Engineering will soon publish an update for its guide to sterile-product manufacturing facilities. The new publication will replace the original guide and contain practical information about technological advances in sterile manufacturing.

The UK's Technology Strategy Board has partnered with the Engineering and Physical Sciences Research Council to invest up to £9 million ($14.2 million) in grant funding with the aim of driving proof-of-concept ideas to pilot technology demonstration for healthcare.

FDA Makes Organizational Changes Within CDER.

Deborah Autor testifies before US Senate HELP committee on requested authorities to improve pharma supply chain.

GSK, Anacor Expand R&D Collaboration; Xoma Announces Management Changes; and More.

USP Expands Presence in India.

FDA's Division of Drug Marketing, Advertising, and Communication issued a letter to Pfizer's vice-president of US Regulatory Affairs regarding its online resources page for Lipitor tablets.

Sweden's Medical Products Agency issues a report calling for strengthening environmental standards for pharmaceutical production within the European Union.

Sanofi outlined its long-term financial objectives this week as the company discussed its strategy in mitigating generic-drug incursion and in generating growth in key therapeutic areas and emerging markets.

Pfizer has completed its cash tender offer for the biopharm company Icagen after extending its initial deadline.

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

Being aware of a forthcoming inspection or how a product was made can make a huge difference.

A report commissioned by FDA evaluates the QbD program.

Growth and change in Brazil and Mexico offer key opportunities for the region's pharmaceutical industry.

A summary of the latest steering committee and expert working groups' meeting.

International Federation of Pharmaceutical Manufacturers and Associations takes global action to improve public health.

After a series of structural changes, the author wonders whether USP is undergoing an identity crisis. USP CEO Roger L. Williams responds.

Valeant Agrees to Acquire Afexa Life Sciences; Merck KGaA Names Robert Yates President of Millipore Division; and More.

USP and the Brazilian National Agency of Sanitary Surveillance are teaming up to develop joint education activities for professionals involved in formulating and using pharmacopeial monograph standards in Brazil.

FDA published a draft guidance that lists recommendations to follow, data to provide, and criteria to meet and describe in new drug applications and abbreviated new drug applications for scored tablets.

EMA announced that a new version of the validation criteria for electronic applications for human medicines comes into effect on Sept. 1, 2011.

African Community Joins ICH's Steering Committee.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued a number of press releases on Aug. 25–26, 2011, regarding the discovery of rogue medicines in packs of Reckitt Benckiser's Nurofen Plus.

To further enhance its position in clinical-trial materials supply, Catalent Pharma Solutions has agreed to acquire the clinical-trial supplies business of Aptuit for $410 million on a cash and debt-fee basis.

Last week, Ben Venue Laboratories decided to exit the contract-manufacturing business during the next several years, thus ending more than 70 years of service in this field. To ensure the supply of medically necessary products, the company will work with its customers to develop and execute long-term transition plans.

Eisai Establishes New Pharma Sales Subsidiary in Mexico; Cangene Names John A. Sedor as President and CEO; and More.

In 2010, FDA recorded nearly 180 drug shortages, triple the number recorded in 2005. Most of the drugs that experienced shortages were sterile injectables, including cancer medications and anesthetics.