Susan Haigney

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

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

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

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

Draft guidance combines and supersedes previous guidance documents.

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

FDA has released Guidance for Industry: Abuse-Deterrent Opioids?Evaluation and Labeling, Draft Guidance

USP revises labeling requirements for Heparin.

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.