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FDA Initial Steps on CBD Explained

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Mintz attorney Joanna Hawana explains FDAs position of regulating cannabis-derived products as shown in recent public announcement...

FDA Denies US WorldMeds Apokyn Petition

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Citing time restrictions, FDA denies without comment a US WorldMeds petition asking for specific treatment of any ANDA citing its ...

FDA Orders Fertility Clinic to Cease Manufacturing

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FDA orders a fertility clinic in San Juan, Puerto Rico, to cease manufacturing due to significant violations of agency regulations...

Evofem Biosciences Re-files NDA for Amphora

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Evofem Biosciences resubmits its NDA for Amphora (L-lactic acid, citric acid and potassium bitartrate), a multipurpose vaginal pH ...

Nurse Sentenced for Insys Fentanyl Kickbacks

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The Justice Department says an advance practice nurse who worked in a pain clinic was sentenced to three years of probation for ac...

Device Sterilization Master File Pilot

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Federal Register notice: CDRH announces an Ethylene Oxide Sterilization Master File Pilot Program that will allow sterilization pr...

Tobacco Product Modifications Compliance Policy

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Federal Register notice: FDA makes available a guidance entitled Compliance Policy for Limited Modifications to Certain Marketed T...

Tusker Medical Ear Infection Tubes Approved

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FDA approves a Tusker Medical PMA for the Tubes Under Local Anesthesia System for delivery of tympanostomy tubes (ear tubes) that ...

Bipartisan Call to Update 21st Century Cures Act

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Reps. Upton and DeGette start a process to improve the 21st Century Cures Act.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes EPH Technologies and Lohxa.