A California recently indicated he would stay a putative class action raising allegations about labeling of “evaporated cane juice” pendin
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FDA Issues Further Nanotechnology Guidance
Late last month, the U.S. Food and Drug Administration issued one draft and three final guidance documents related to the use of nanotechnology in reg…
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Federal Court Dismisses Cane Juice Class Under Primary Jurisdiction Doctrine
A California federal court took a second look and decided to dismiss a proposed class action related to the ingredient “evaporated cane juice&rd…
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FDA Issues Draft Guidance on Social Media
The U.S. Food and Drug Administration recently took a small step towards providing industry with the long-awaited guidance on how pharmaceutical maker…
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CHPA Comments on Draft FDA Guidance on Nanotechnology
Last week, the Consumer Healthcare Products Association (CHPA) submitted comments on the FDA’s draft guidance on nanotechnology, “Consideri…
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FDA Releases Draft Guidance on Nanotechnology
The U.S. Food and Drug Administration last week released draft guidance designed to move the process forward of providing its regulated industries wit…
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PhRMA Issues New Principles on Clinical Trials
Readers of MassTortDefense know how the conduct and results of clinical trials can reach out and affect later product liability litigation: plaintiffs…
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Device Group Comments on FDA Draft Guidance on Risk Information
Readers of MassTortDefense know how FDA regulatory treatment of advertising and promotion can impact product liability litigation involving drugs and …
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FDA Issues New Draft Guidance on Presenting Risk Information
The FDA recently issued a new draft Guidance for Industry titled “Presenting Risk Information in Prescription Drug and Medical Device Promotion.
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FDA Issues Guidance On Distribution Of Medical And Scientific Articles Regarding Off-Label Usage
The FDA has finalized guidelines for how manufacturers can distribute information to doctors about unapproved uses for drugs or medical devices. The &…
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