Articles by Susan Haigney - Pharmaceutical Technology

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Articles by Susan Haigney

FDA Releases SUPAC Guidance

Apr 2, 2013

Draft guidance combines and supersedes previous guidance documents.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

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

FDA Releases Guidance on Opioids

Jan 15, 2013

FDA has released Guidance for Industry: Abuse-Deterrent Opioids?Evaluation and Labeling, Draft Guidance

USP Changes Heparin Labeling Requirement

Nov 5, 2012

USP revises labeling requirements for Heparin.

CDER to Expand Office of Generic Drugs

Sep 11, 2012

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.

EMA Phases out Follow-Up Measures

Aug 9, 2012

The European Medicines Agency (EMA) will soon be phasing out follow-up measures to marketing authorisations in place of a new system of classification that will be introduced in a stepwise manner.

Congress Passes Generic Drug Act

Jul 10, 2012

On July 9, 2012, Congress passed the Generic Drug User Fee Act in an effort to expedite the process of bringing generic drugs to market. The Act authorizes the collection of user fees from generic-drug manufacturing companies for the first time in the industry's history.

FDA Issues Draft Guidance on OTC Products that Contain Acetaminophen

Jul 3, 2012

FDA has issued a draft guidance on the labeling of OTC products that contain acetaminophen. The draft guidance would give manufacturers an alternative option to properly clarify the risk of liver damage in OTC acetaminophen-containing products.

FDA Updates List of Warning Letters

Jun 26, 2012

FDA has updated its website to include the latest Warning Letters issued to pharmaceutical companies by the Office of Prescription Drug Promotion and the Center for Drug Evaluation and Research.

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