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Prices Increases Not Justified for 7 Drugs: ICER

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The Institute for Clinical and Economic Review identifies nine drugs whose 2017-2018 price increases were not supported by evidenc...

New Info Collection on FDA Fellowship Programs

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Federal Register notice: FDA submits to OMB a new information collection conflict of interest information for non-employee fellows...

6 FDA Software Exemption Guidances Analyzed

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Akin Gump attorneys highlight provisions in a package of six guidances issued by FDA to clarify its position on software exemption...

FDA Seeks Consumer Reps for Committees

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Federal Register notice: FDA seeks consumer organizations interested in participating in selecting voting and nonvoting consumer r...

Ban Pre-Term Birth Drug Makena: Public Citizen

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Public Citizen calls on FDA to order Amags Makena off the market because it is ineffective at reducing the rate of some pre-term b...

Multiple Violations at Herbal Healer Academy

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FDA warns Herbal Healer Academy about multiple violations of the Federal Food, Drug, and Cosmetic Act involving many of its homeop...

FDA Funds 2 Natural History Studies

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FDA awards $4.1 million to fund two new research grants for natural history studies in rare diseases to help design efficient clin...

Class 1 Recall of Medtronic Guide Catheter

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FDA classifies as Class 1 a Medtronic recall of its 6 French Sherpa NX Active Guide Catheter due to a risk of the outer material s...

General, Specific Comments on ICH Clinical Studies Guidance

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Stakeholders generally praise a revised ICH guideline on clinical studies and suggest changes.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Herbal Healer Academy and NuCare Pharmaceuticals.