Quality Systems

Articles

The traditional method of conveying information in the brief summary of a printed prescription-drug advertisement is neither the most comprehensible nor the most preferred by consumers, according to an FDA study.

FDA Study Finds Traditional Print Drug Ads Unclear

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The US Supreme Court ruled in favor of Roche in a patent-dispute case the pharmaceutical company had with Stanford University in a 7-2 vote.

US Supreme Court Rules in Favor of Roche in University Patent-Rights Case

An independent report released by the European Medicines Agency highlighted a number of recommendations to aid the agency in its communication of the benefits and risks of medicines.

Independent Expert Advises EMA on Benefit/Risk Communication

Industry associations will soon provide new recommendations about extractables and leachables.

The Means to Monitor Chemical Migration

FDA has released a list of its strategic priorities for the next five years to address new global challenges.

FDA Releases Strategic Priorities for 2011-2015

The need for greater process understanding raises the bar for suppliers.

A QbD World for Suppliers

On Mar. 23, 2011, sanofi-aventis offered $7 billion in notes to fund its acquisition of Genzyme. The notes are offered in six tranches scheduled to come due between 2012 and 2021, and the interest rates range from 0.05% to 4%.

Sanofi Issues Bonds to Fund Genzyme Acquisition

The Bulk Pharmaceutical Task Force (BPTF) of the Society for Chemical Manufacturers and Affiliates (SOCMA) and the European Fine Chemicals Group (EFCG) of the European Chemical Industry Council (CEFIC) are calling on FDA to mandate inspections of foreign active pharmaceutical ingredient (API) manufacturing sites with the cost borne by those sites being inspected. Both organizations have indicated a willingness to pay fees for these inspections when performed on their member-owned facilities that are located outside the United States.

SOCMA and EFCG Urge for Reform in FDA Inspections of Foreign Drug-Manufacturing Facilities

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

A number of European public health and transparency campaigners believe that conflict of interest rules may have been breached with the EMA's decision to allow its former Executive Director, Thomas Lönngren, to take up an advisory role within the private pharmaceutical sector.

EMA Challenged Over Conflict-of-Interest Case

Anurag S. Rathore is a professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi,  Tel. +91.9650770650, asrathore@biotechcmz.com.

The author provides an overview of QbD implmentation for biopharmaceuticals.

Quality by Design