Articles by Susan Haigney - Pharmaceutical Technology

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Articles by Susan Haigney
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FDA Creates Partnership to Battle Anti-Malaria Counterfeit Drugs

Apr 24, 2013
By: Susan Haigney

FDA will use a new anticounterfeiting tool to detect fake medicines.

Compounding Pharmacies Recall Products

Apr 16, 2013
By: Susan Haigney

FDA inspections of compounding pharmacies manufacturing sterile-drug products lead to voluntary recalls.

FDA Commissioner Claims Resistance to Compounding Pharmacy Inspections

Apr 12, 2013
By: Susan Haigney

FDA inspections of compounding pharmacies manufacturing sterile products reveal non-sterile conditions.

FDA Requests Almost $5 Billion for 2014 Budget

Apr 12, 2013
By: Susan Haigney

FDA's Fiscal Year 2014 budget request includes more than $10 million above the 2012 budget for inspections of products manufactured in China.

FDA Releases SUPAC Guidance

Apr 2, 2013
By: Susan Haigney

Draft guidance combines and supersedes previous guidance documents.

The Lifecycle Change of Process Validation and Analytical Testing

Industry experts discuss the effect FDA's 2011 process validation guidance has had on industry.
Mar 2, 2013
By: Susan Haigney

Industry experts discuss the effect FDA's 2011 process validation guidance has had on industry.

FDA Releases Guidance on Opioids

Jan 15, 2013
By: Susan Haigney

FDA has released Guidance for Industry: Abuse-Deterrent Opioids?Evaluation and Labeling, Draft Guidance

USP Changes Heparin Labeling Requirement

Nov 5, 2012
By: Susan Haigney

USP revises labeling requirements for Heparin.

CDER to Expand Office of Generic Drugs

Sep 11, 2012
By: Susan Haigney

As a result of the passage of the Generic Drug User Fee Amendments Act, Janet Woodcock, director of the Center for Drug Evaluation and Research, announced her plan to reorganize the Office of Generic Drugs (OGD) into a super office that would include subordinate offices. The new super office would report directly to Director Woodcock, with Greg Geba continuing his role as OGD director.

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