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How to Manage Effective Leadership when Change is the Only Constant

November 2, 2012
By: Tracy Thurkow, Karen Gorman, Paula Butte
Pharmaceutical Technology

A disciplined approach to changing behavior can achieve change agility.

FDA and the Importance of Confidentiality

October 2, 2012
By: David L. Rosen
Pharmaceutical Technology

Recent news stories have reported that FDA scientists have been suspected of leaking confidential, commercial, and trade secret information to the media.

Technology Transfer: Protecting the True Public Interest

September 2, 2012
By: Jim Greenwood
Pharmaceutical Technology

Ties between the biotechnology industry and university research are crucial.

Weighing Access and Affordability

September 1, 2012
By: Kenneth I. Kaitin, Joshua P. Cohen
Pharmaceutical Technology

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

Enactment of FDA Reform Act Improves Drug Safety

August 2, 2012
By: John DiLoreto
Pharmaceutical Technology

New law provides FDA with the resources it needs to safeguard drug supply chain.

Requirements for Electronic Records Contained in 21 CFR 211

July 18, 2012
By: Orlando López
Pharmaceutical Technology

The author discusses the regulatory requirements for electronic records contained in Title 21 CFR Part 211 and how they overlap with the requirements set forth in Title 21 CFR Part 11.

Future Innovation

July 2, 2012
Pharmaceutical Technology

Presidents of leading associations offer views on the industry's future.

Biosimilar Developers Face a Reference-Product Dilemma

June 2, 2012
By: Fiona Greer
Pharmaceutical Technology

Does global development have to entail multiple comparability studies?

The Growing Orphan-Drug Paradigm

May 2, 2012
By: Rita E. Numerof, Michael N. Abrams
Pharmaceutical Technology

How niche strategies can offer mainstream potential for biopharmaceutical companies.

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