Articles by Angie Drakulich - Pharmaceutical Technology

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Articles by Angie Drakulich

FDA's Hamburg Calls for Generic-Drug User Fees

Sep 23, 2010

US Food and Drug Administration Commissioner Margaret A. Hamburg spoke at the Generic Drug User Fees Public Meeting last Friday, Sept. 17, 2010, about enacting user fees for the generic-drug sector.

FDA Launches Public System to Monitor Its Own Performance

Sep 9, 2010

The US Food and Drug Administration launched last week a performance management system designed to advance President Obama's commitment to transparency, public participation, and governmental collaboration.

Above and Beyond

Industry efforts toward global healthcare surpass average expectations.
Sep 2, 2010

Industry efforts toward global healthcare surpass average expectations.

FDA and EMA Seek Candidates for GMP Inspection Pilot

Aug 19, 2010

The US Food and Drug Administration and European Medicines Agency (EMA) are looking for drug manufacturing companies to participate in their joint good manufacturing practice (GMP) inspection pilot program.

Managing Expectations and Deliverables: A CMO Roundtable

Leading CMOs share their experiences with regard to client expectations and performance indicators as well as strategies for adapting to the changing contract-manufacturing environment. This article is part of the 2010 Outsourcing Resources special issue.
Aug 1, 2010

Leading CMOs share their experiences with regard to client expectations and performance indicators as well as strategies for adapting to the changing contract-manufacturing environment. This article is part of the 2010 Outsourcing Resources special issue.

Third-Party Outsourcing of IT Services on the Rise

Jul 29, 2010

A new report from the International Data Corporation (IDC) shows that life-science companies are increasingly using third-party outsourcing firms to augment or replace their information technology services.

FDA Joins Chemical-Screening Collaboration

Jul 22, 2010

The US Food and Drug Administration has joined the Tox21 collaboration, which aims to develop ways to more effectively predict how chemicals will affect the body and environment.

Castellani to Replace Tauzin as Head of PhRMA

Jul 15, 2010

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.

USP Works With Philippines to Strengthen Drug Quality

Jul 15, 2010

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.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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