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Covid-19 Guidance Listing Updated

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Federal Register notice: FDA updates its listing of guidance documents related to the Covid-19 public health emergency.

AbbVies Dalvance Approved for Pediatric Patients

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FDA approves AbbVies Dalvance (dalbavancin) for treating acute bacterial skin and skin structure infections in pediatric patients....

Comments Sought on Drug Scheduling

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Federal Register notice: FDA seeks comments about abuse potential, actual abuse, medical usefulness, trafficking, and impact of sc...

Guide on Field Alert Reports

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Federal Register notice: FDA makes available a final guidance entitled Field Alert Report Submission: Questions and Answers.

Class 1 Recall for Philips Respironics Ventilators

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FDA classifies as Class 1 a Philips Respironics recall of its continuous and non-continuous ventilators due to concerns about the ...

AstraZenecas Bydureon OKd for Pediatric Diabetics

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FDA approves AstraZenecas Bydureon and Bydureon BCise (exenatide extended-release) injection for use in addition to diet and exerc...

Info Collection on Rx Drug Advsertising

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Federal Register notice: FDA sends to OMB an information collection extension entitled Prescription Drug Advertising--21 CFR Part ...

Medical Product Communications Info Collection

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Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Product Communications That Are Con...

Generic Animal Drug User Fee Rates

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Federal Register notice: FDA announces the generic animal user fee rates and payment procedures for fiscal year 2022.

3 More Former FDAers Join Greenleaf Health

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Greenleaf Health adds former FDAers Julia Barrett, Chris Leptak, and Grace McNally to its regulatory consulting staff.