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Heron Therapeutics NDA for HTX-011

[ Price : $8.95]

Heron Therapeutics files an NDA for HTX-011, a long-acting, extended-release formulation of the local anesthetic bupivacaine in a ...

Cell Phone Safety Limits Remain Acceptable: Shuren

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CDRH director Jeffrey Shuren says current cell phone radiofrequency exposure limits are acceptable to protect the public health.

Number of FDA Port of Entry Agents Up

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FDA outlines for the House Energy and Commerce Committee its staffing levels of Port of Entry special agents tasked with stopping ...

FDA Pulls 2 Medical Device Proposed Rules

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FDA says it will pull two proposed regulations that need further work if they are to be finalized.

Court Backs FDA in MiraLax OTC Decision

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The DC Circuit Appeals Court says FDA did not act arbitrarily or capriciously in determining that there is no meaningful differenc...

Information Collection Extension for Bar Code Labels

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Federal Register notice: FDA seeks comments on an information collection extension entitled Bar Code Label Requirement for Human D...

FDA Clears EliTechGroup Herpes Test

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FDA clears an EliTechGroup 510(k) for its HSV 1&2 ELITe MGB Real-Time PCR assay with the ELITe InGenius sample-to-result instrumen...

Stimwave Mobile Platform Cleared for Pain Device

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FDA clears a Stimwave Technologies 510(k) for the WaveCrest Mobile iOS Platform patient controllers for opioid-free pain managemen...

FDA Speeding Drug Approvals: Pitts

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Former FDAer Peter Pitts praises agency efforts to speed approval of generic and branded drugs.

FDA Science Advisory Board Meeting 12/4-5

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Federal Register notice: FDA announces a 12/4-5 meeting of the Science Advisory Board to the National Center for Toxicological Res...