Articles by Angie Drakulich - Pharmaceutical Technology

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Articles by Angie Drakulich

Global Healthcare on the Ground: Global Health Progress Initiative

The Global Health Progress collaboration works to improve healthcare delivery in the developing world.
Jan 2, 2011

The Global Health Progress collaboration works to improve healthcare delivery in the developing world.

FDA to Officially Join PIC/S

Dec 30, 2010

After five years of discussions, the US Food and Drug Administration is joining the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Cooperation Scheme (PIC Scheme), known together as PIC/S.

EMA Opens Registry for Small and Medium Companies

Dec 23, 2010

The European Medicines Agency launched on December 20, 2010, a public registry about small and medium-sized enterprises (SME) that includes information about SME-registered companies.

PDUFA Discussions Continue, New Review Models Proposed

Dec 9, 2010

The US Food and Drug Administration posted on its website the minutes of the latest meetings between the agency and industry, and among stakeholders, regarding the reauthorization of the Prescription Drug User Fee Act V.

Global Healthcare on the Ground: Differential Pricing

Tiered pricing is used throughout industry to help increase affordability and access to drugs in the developing world.
Dec 2, 2010

Tiered pricing is used throughout industry to help increase affordability and access to drugs in the developing world.

FDA Issues New Guidance for Industry on ANDAs: Impurities in Drug Products

Dec 2, 2010

The US Food and Drug Administration issued late last week a new guidance for industry on impurities in drug products.

EMA Committee Makes Decisions on Opioids, Follow-on Biologics

Nov 24, 2010

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued on November 19 a summary of its latest meeting.

EMA Issues Draft Principles on Postapproval Change Management

Nov 11, 2010

The European Medicines Agency published a draft list of questions and answers on postapproval change-management protocols last week.

Industry Needs New Approach To Manage Growing Supply-Chain Complexity

Nov 4, 2010

The growth in pharmaceutical outsourcing is creating a more complex and risky supply-chain environment, according to a report issued last week.

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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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