Articles by Susan Haigney - Pharmaceutical Technology

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Articles by Susan Haigney

PDA Revises Technical Report on Sterilized Products

May 22, 2012

PDA Revises Technical Report on Sterilized Products

PDA Releases Technical Report on TBA and TCA Odors and Taints

May 22, 2012

The Parenteral Drug Association has released guidance on the detection and mitigation of 2,4,6-tribromoanisole and 2,4,6-trichloroanisole taints and odors in pharmaceutical and healthcare products.

CDER Ombudsman Releases Annual Report

May 15, 2012

The Center for Drug Evaluation and Research Ombudsman's office released its annual report detailing the common questions and complaints received by the office in 2011. A total of 461 inquiries was received, an increase of 11% from 2010. The majority of inquiries, 60%, originated from industry, with consumers accounting for 23%, healthcare providers 7%, FDA employees 5%, and other 5%.

FDA Issues Warning Letters to Ten Companies for Lack of Safety Evidence

May 1, 2012

FDA has issued Warning Letters to 10 companies that manufacture and distribute dietary supplements that contain dimethylamylamine. FDA cited the companies for marketing the supplements without submitting evidence that the products are safe.

FDA Reports Improvement in Postmarket Drug Oversight

Apr 24, 2012

FDA highlights success of CDER's drug-monitoring program.

FDA Updates Sentinel Initiative Status

Mar 22, 2012

In a presentation published on FDA's website on Mar. 15, 2012, Janet Woodcock, director of CDER, outlined the current status and future plans for FDA's Sentinel Initiative, an electronic drug safety tracking system established as part of the FDA Amendments Act of 2007.

FDA Takes Proactive Steps to Prevent Cancer Drug Shortages

Mar 1, 2012

On Feb. 21, 2012, FDA announced steps the agency plans to take to increase the declining supply of certain cancer drugs. These steps came in response to President Obama's Oct. 31, 2011 Executive Order.

McNeil Voluntarily Recalls Infants' Tylenol Oral Suspension Product

Feb 23, 2012

On Feb. 17, 2012, McNeil Consumer Healthcare, a division of McNeil-PPC, a subsidiary of Johnson & Johnson, voluntarily recalled approximately 574,000 bottles of its OTC pain reliever and fever reducer Infants' Tylenol Oral Suspension, 1 oz. Grape. The voluntary recall was initiated after consumers complained of having difficulty using the SimpleMeasure dosing system.

White House's 2013 Budget Includes FDA Increases

Feb 16, 2012

President Barack Obama released his budget proposal for fiscal year 2013. Included in the proposed budget is a $654-million increase in FDA funding, for a total FDA budget request of $4.49 billion.


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