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Draft Guide on Biosimilar Clinical Immunogenicity

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Clinical Immunogenicity Considerations for Biosimilar and I...

FDA Approves QuantiFeron-TB Plus Diagnostic

[ Price : $8.95]

FDA approves a Qiagen and DiaSorin PMA for the automated workflow for QuantiFeron-TB Plus, a fourth-generation test for latent tub...

Zebra Medical 510(k) Cleared for HealthCXR

[ Price : $8.95]

FDA clears a Zebra Medical Vision 510(k) for its HealthCXR device intended for use in identifying and triaging pleural effusion in...

B. Braun Recalls Blood Administration Sets

[ Price : $8.95]

FDA says B. Braun is recalling 43,026 blood administration sets that may leak at the joint between blood filters and tubing.

Man Indicted for Illegal Animal Drug

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A Puerto Rico federal grand jury indicts an individual on charges relating to shipments of an illegal, adulterated, and misbranded...

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...