02.18.14 -- Janet Woodcock's Quality Agenda At CDER
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By Wayne Koberstein, Executive Editor
Speaking in whole sentences may become an ever-rarer practice in this, the “Abbreviated Age” of texts and tweets — but Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research (CDER), is someone who speaks in whole paragraphs. She is not reading from a script; she spontaneously composes succinct, lucid, and informative statements based on logic and knowledge, requiring none of the editing we usually expect with extemporaneous speech. Woodcock speaks with the perspective of a builder, not an observer. Over many years, she has helped shape and construct the agency as it is today. Consequently, she has become the most consistent, reliable voice of the FDA for most people in the life sciences industry.
By Chad Lorensen, Schenck AccuRate
Metering dry powders in the pharmaceutical industry is not a new idea. Several common applications have been using gravimetric and volumetric dry material feeders for many years. Until recently, these feeders were customized versions of industrial or food-grade equipment, or one-off-type machines engineered for a specific application. Driven by increasing demand, an equipment manufacturer embarked on an effort to create a standard dry material feeder engineered to meet the pharmaceutical industry'’s needs.
By Laura Studwell, Loma Systems
Prices for pharmaceutical products have been increasing at an accelerated rate for more than a decade. The increases are being driven by increased product competition, coupled with the growing cost of research and development, the increase in patent laws, and greater government legislation, as well as the price transparency created by insurance companies worldwide.
By Gary Partington, Walker Barrier Systems
While price is certainly an important reason for buying any piece of capital equipment, it is not always the top reason. There are important considerations to examine when selecting an isolator supplier to be certain that you are getting what you are paying for, before the purchase order is written.
By Malcolm McLaughlin, Alconox, Inc.
What are important questions to consider when selecting an aqueous cleaner? Today's aqueous critical-cleaning detergents are blended for specific applications — substrate, degree of soil load, and cleaning process — these are all important considerations when selecting a detergent.
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