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AdvaMed Wants Better Section 517A Definitions

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AdvaMed asks FDA to improve definitions in a draft guidance on implementation of a new regulatory provision on the CDRH appeals pr...

Generic Drug Makers Seek Delay on New Stability Recommendations

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The Generic Pharmaceutical Association says FDA should give generic makers a year to implement stability changes articulated in it...

Repackager Recalls Mislabeled Drugs

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Aidapak Services recalls specific unit dose repackaged products sent to 25 hospital inpatient pharmacies in Washington, Oregon, Ca...

Covidien Recalls Monoject Prefill Flush Syringes

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Covidien begins a recall of certain lots of Monoject prefill flush syringes due to the risk that a number of the syringes were fil...

FDA OKs Supernus NDA for Epilepsy Drug

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FDA approves a Supernus Pharmaceuticals NDA for Trokendi XR (topiramate) for treating epilepsy.

Drug and Device Recalls Surge Last Quarter: Report

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Drug and device recalls surge during the second quarter this year, according to a new Stericycle ExpertRecall report.

FDA Pilot Program on Drug Supply Chain Integrity

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FDA announces a two-year Secure Supply Chain Pilot Program as an effort to prevent adulterated, misbranded, or unapproved drugs fr...

Guidance on Blood Donor Malaria Risks

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Federal Register notice: FDA releases a Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and Produ...

Advisory Committee to Review Vascepa sNDA

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Federal Register notice: FDA announces a meeting of its Endocrinologic and Metabolic Drugs Advisory Committee on 10/16 that will ...

to-BBB Gains Approval for Phase 2 Brain Metastases Drug

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to-BBB gains IND approval to proceed with a Phase 2 clinical study involving doxorubicin in patients with brain metastases from br...