Susan Haigney

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

FDA inspections of compounding pharmacies result in FDA-483 citations.

FDA's FY 2014 budget includes more than $10 million above the 2012 budget for inspections of products and ingredients manufactured in China.

BioPharm International spoke with industry experts about the effect FDA's 2011 process validation guidance has had on industry.

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.

USP Hosts Symposium on Science and Standards

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