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PerkinElmer 510(k) Cleared for Vasculitis Assays

[ Price : $8.95]

FDA clears a PerkinElmer 510(k) for its EuroImmun ANCA IFA and Europlus Granulocyte Mosaic assays and their use with the EuroPatte...

Firm Selling Unapproved Ycellbio Kit

[ Price : $8.95]

FDA cautions South Koreas Ycellbio Medical Co. that it is marketing its Ycellbio kit in the U.S. without required premarket approv...

No Final Regulation Yet on OTC Hearing Aids

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FDA cautions that no device can yet legally be considered an over-the-counter hearing aid within the definition in the FDA Reautho...

Pharmacy Compounding Advisory Committee Meeting 9/12

[ Price : $8.95]

Federal Register notice: FDA announces a 9/12 Pharmacy Compounding Advisory Committee meeting.

Workshop on Otic and Vestibular Toxicity

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Federal Register notice: FDA announces an 8/21 public workshop entitled Regulatory Perspectives on Otic and Vestibular Toxicity: C...

Companies Answer FDA PPI Questions

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Four drug companies respond to an FDA request for input on developing guidance on assessing pH-dependent absorption and potential ...

Sarbanes Drug Cost Bill Introduced

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Rep. John Sarbanes introduces legislation to require biologic and biosimilar drug manufacturers to report potential pay-for-delay ...

Med-El USA Gains De Novo Marketing for Hearing Device

[ Price : $8.95]

FDA grants Med-El USA de novo marketing for its Bonebridge bone conduction hearing implant system for individuals 12 years and old...

Dont Approve Remoxy ER NDA: PMRS

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Pharmaceutical Manufacturing Research Services asks FDA not to approve an NDA for Remoxy ER or similar opioid NDAs.

FDA Opens New Staff Recruitment, Retention Campaign

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FDA launches a new staff recruitment and retention campaign.