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Ban Pre-Term Birth Drug Makena: Public Citizen

[ Price : $8.95]

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.

FDA Approves Clinuvels Phototoxic Reactions Drug

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FDA approves a Clinuvel NDA for Scenesse (afamelanotide) for increasing pain-free light exposure in adult patients with a history ...

California Law Combats Pay-for-Delay Agreements

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California becomes the first state in the nation to approve a bill to combat so-called pay-for-delay agreements between innovator ...

NuCare Pharmaceuticals Listing Violations

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FDA warns NuCare about many instances in which its listing information does not comply with applicable requirements.

Jury Awards $8 Billion in Risperdal Case

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A Philadelphia jury delivers an $8 billion punitive verdict against Johnson & Johnson and its alleged improper marketing of the an...