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New Phase 3 Data Show TAK-620 (maribavir), an Investigational Drug for the Treatment of Transplant Recipients with Refractory/Resistant Cytomegalovirus (CMV) Infections, Meets Primary Endpoint

The Pharma Data

2002;S1-S12. The European Blood and Marrow Transplantation Textbook for Nurses: under the Auspices of EBMT. Complement-fixing antibodies against cytomegalovirus in different parts of the world. 1973;49:103-6. 3 De la Hoz, RE., J Clin Virol. Cytomegalovirus infection in transplant recipients.

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Let's Quit Sugar With Audiobook – Let's Quit Sugar

The Pharma Data

The trans-fat ban–food regulation and long-term health. 2002 Jun;10(6):478-88. Regulation of glucose metabolism from a liver-centric perspective. Adipose tissue regulates insulin sensitivity: role of adipogenesis, de novo lipogenesis and novel lipids. Biochem Cell Biol. 2015 Oct;93(5):466-71. DOI: 10.1139/bcb-2014-0064.

Disease 52
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A Painful Preemption Decision

Drug & Device Law

Then, the decision makes a hash of the relevant administrative record, ignoring what the preemptive FDA regulations said in favor of material from the Federal Register that never actually made it into the regulations themselves. The FDA also promulgated an acetaminophen-specific OTC regulation. 201.326(a)(1).

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The Medical Device Labeling Exception for “Commonly Known” Hazards

Drug & Device Law

The FDA’s regulations for medical device labeling generally require that such labeling include “any relevant hazards, contraindications, side effects, and precautions.” Similarly to Robinson : Defendants argue that [the expert’s] personal opinions conflict with controlling federal regulations, citing 21 C.F.R. 801.109(c).

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FDA and Off-Label Communication – Getting Closer to Truth

Drug & Device Law

357 (2002); United States v. If unfettered truthful off-label promotion is permissible, then the incentives for regulated entities to spend the large amounts of time and money now required to submit new uses of already approved FDA-regulated products for additional approvals would be reduced. E.g. , Sorrell v. IMS Health Inc. ,

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