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SciGen Recalls Irbesartan for Contamination Potential

[ Price : $8.95]

FDA says SciGen is recalling specific lots of its irbesartan due to a potential for contamination.

Vanda Web Page for 2 Drugs False, Misleading: OPDP

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CDERs Office of Prescription Drug Promotion warns Vanda about a Web page promoting its Fanapt and Hetlioz that doesnt contain any ...

Keytruda with Chemo Approved for Lung Cancer

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FDA approves Mercks Keytruda in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment ...

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...

Draft Guide on Dried Plasma Products

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Federal Register notice: FDA makes available a draft guidance entitled Considerations for the Development of Dried Plasma Products...

10 NDA Approvals Withdrawn by FDA

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Federal Register notice: FDA withdraws approval of 10 NDAs from multiple applicants after they notified the agency that the drug p...