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FDA Guide on Patient Remote Monitors

[ Price : $8.95]

FDA posts a revised guidance entitled Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monito...

FDA Virtual Regulated Bioanalysis Workshop

[ Price : $8.95]

FDA announces a 6/30 virtual meeting entitled Regulated Bioanalysis Workshop: Requirements and Expectations.

Adamas sNDA for Parkinsons Drug

[ Price : $8.95]

FDA accepts for review an Adamas Pharmaceuticals supplemental NDA for Gocovri (amantadine) as a treatment for off episodes in Park...

Transit Scientific XO PTA Scoring Sheath Cleared

[ Price : $8.95]

FDA clears a Transit Scientific 510(k) for its XO Score Percutaneous Transluminal Angioplasty Scoring Sheath platform for use in i...

Fed Reg on ICH Solvents Corrected

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Federal Register notice: FDA corrects a 5/27 notice on a guidance entitled Q3C (R8) Recommendations for the Permitted Daily Exposu...

EUAs Issued and Reissued During Covid Emergency

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Federal Register notice: FDA announces the issuance and reissuance of Emergency Use Authorizations (EUAs) for certain medical devi...

Testing Supply Substitution Strategies

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FDA releases a PowerPoint slide show describing a new Web resource for labs performing Covid-19 tests that are authorized.

Fitbit Emergency Use Ventilator

[ Price : $8.95]

FDA grants Fitbit an emergency use authorization for its emergency ventilator, Fitbit Flow, for use during the Covid-19 public hea...

FDA Reminder on Proper Transport Media

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FDA reminds laboratories to use transport media that are compatible with Covid-19 testing platforms and the processes used in thei...

FDA Regulatory Flexibility for Antimicrobials Analyzed

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Harvard Medical School researchers say that in the last 30 years antimicrobial products have frequently qualified for FDA expedite...