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2 Innovations Can Change Drug Production: Consultants

[ Price : $8.95]

Consultants Marcus Ehrhardt and Peter Behner say two drug production innovations will significantly change the currently stagnant ...

Point-of-Care Communication Channel Growing: Consultants

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A ZS Associates study says point-of-care communications is growing much faster than overall direct-to-consumer communications.

FDA Approves Novartiss Signifor for Treating Acromegaly

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FDA approves a Novartis NDA for Signifor (pasireotide) long-acting release for treating patients with acromegaly who have had an i...

David Kessler Wrong on 510(k) Laws Intent, Lawyer Says

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Medical device lawyer Larry R. Pilot corrects a Wall Street Journal statement by former FDA commissioner David Kessler that the in...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Repromed Fertility Center, Karl Storz GmbH, and Voss Plastics.

QS Violations Found in Karl Storz Endovision

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FDAs New England District Office warns Karl Storz Endovision about Quality System violations at its Charlton, MA, production facil...

FDA Study on Potential Changes for QT Cardiac Safety Studies

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An FDA co-designed study suggests that drug developers could conduct robust cardiac safety characterizations several years earlier...

FDAs First CLIA Waiver Goes to Syphilis Rapid Test

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FDA grants the first-ever Clinical Laboratory Improvement Amendments (CLIA) waiver for Veda Labs (Alencon, France) rapid screening...

FDA Clears Olympus Narrow Band Imaging Technology

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FDA clears an Olympus 510(k) for its Narrow Band Imaging to enable effective targeting of biopsies not seen under white light.

Animal Drug Regs Reflect Sept., Oct. Approvals

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Federal Register Notice: FDA is amending the animal drug regulations to reflect September and October approval actions for NADAs a...