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By Quality Digest

(FDA: Rockville, Maryland) -- The Food and Drug Administration (FDA) plans to implement several improved policies and procedures strengthening its management advisory committees. The improvements ... [Read More]

Quality Digest’s picture
By Quality Digest

(FDA: Rockville, Maryland) -- The U.S. Food and Drug Administration (FDA) issued a final regulation that makes early phase 1 clinical drug development safe and efficient by enabling a phased ... [Read More]

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By Quality Digest

(ASPEX: Pittsburgh, Pennsylvania) -- Following the U.S. Food and Drug Administration’s recent decision to join European and Australian authorities in the inspection of overseas drug manufacturing ... [Read More]

Janis V. Olson’s picture
By Janis V. Olson

Poor records and poor management of good records can trigger needless costs, penalties, and public embarrassment for Food and Drug Administration-regulated companies. As if managing your own ... [Read More]

Quality Digest’s picture
By Quality Digest

(FDA: Washington, D.C.) -- The U.S. Food and Drug Administration (FDA) issued a final regulation that makes early phase-1 clinical drug development safe and efficient by enabling a phased approach ... [Read More]

Quality Digest’s picture
By Quality Digest

(FDA: Rockville, Maryland) -- The Food and Drug Administration is seeking volunteers from pharmaceutical companies to participate in a pilot quality-by-design (QbD) program. The purpose of ... [Read More]

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By Quality Digest

The U.S. Food and Drug Administration (FDA) is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. Under new regulations that govern ... [Read More]

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By Quality Digest

(FDA: Washington, D.C.) -- The U.S. Food and Drug Administration’s “Food Protection Plan Progress Report,” in conjunction with the “Interagency Working Group on Import ... [Read More]

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By Quality Digest

(Quality Digest: Chico, California) -- Be sure to check out the new, fully redesigned Quality Digest homepage and web site. Not only is the new site more aesthetically pleasing than ever, ... [Read More]

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By Quality Digest

(Octagon Research Solutions Inc.: Wayne, Pennsylvania) -- Octagon Research Solutions Inc., a provider of software and services to the life sciences industry, has announced a new service offering, ... [Read More]

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