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Docket Opened on E-Cigarettes

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Federal Register Notice: FDA establishes a docket to gather scientific information about electronic cigarettes.

Tobacco Collection of Info Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on a generic clearance for collecting quantitative data ...

Guidance on OTC Acetaminophen Drugs and Skin Reactions

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Federal Register Notice: FDA releases a draft guidance: Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Pro...

Transcripts Posted on FDA Medical Device 3-D Printing Workshop

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FDA posts transcripts from its 10/8-9 public workshop on Additive Manufacturing of Medical Devices: An Interactive Discussion on t...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Cell Vitals, Greiner Bio One Brasil Produtos, Jansen Enterprises, LLC dba Health...

FDA Drug SUPAC Manufacturing Equipment Change Addendum

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FDA posts a guidance on Scale-up Post-approval Changes: Manufacturing Equipment Addendum to help manufacturers determine the docum...

Guidance on Infusion Pump Submissions

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The agency posts a final guidance on Infusion Pumps Total Product Life Cycle to assist industry in preparing premarket submissions...

Medical Product Firms Being Hacked Over Sensitive Info

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An Internet security firm says it is currently tracking a group that targets the email accounts of senior employees at healthcare ...

Amarin Pharma Petition on Vascepa Rejected by FDA

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FDA denies an Amarin Pharmaceuticals Ireland petition asking it to impose specific bioequivalence testing requirements on any ANDA...

Class 1 Recall of Synthes Titanium Matrix Spine Screws

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Synthes begins a Class 1 recall of its Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws, reporting that two nonc...