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Guide on Insulin Biosimilar Immunogenicity

[ Price : $8.95]

FDA issues a draft guidance on Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.

Renovia Next-Gen Leva Pelvic Therapeutic Cleared

[ Price : $8.95]

FDA clears a Renovia 510(k) for its next-generation Leva Pelvic Digital Therapeutic for strengthening pelvic floor muscles and tre...

Complete Response on Adamis High-Dose Naloxone

[ Price : $8.95]

FDA issues Adamis Pharmaceuticals a complete response letter on its NDA for Adamis ZimHi (naloxone) high-dose injection for treati...

OPDP Hits Triferic Web Page Promotion

[ Price : $8.95]

CDER Office of Prescription Drug Promotion sends Rockwell Medical an untitled letter after reviewing the companys Triferic Web pag...

Endo BLA Accepted for Cellulite Therapy

[ Price : $8.95]

FDA accepts for review an Endo International BLA for collagenase clostridium histolyticum (CCH) for treating cellulite in the butt...

Trump Extends FDA, Other Funding for 30 Days

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President Trump signs a short-term continuing resolution that funds FDA and other agencies at FY 2019 funding rates through 12/20.

SK Life Sciences Seizure Drug Approved

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FDA approves a SK Life Science NDA for Xcopri (cenobamate tablets) for treating partial-onset seizures in adults.

Panel Summary on Amalgam, Other Metal Devices

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FDA posts a summary of the deliberations during an 11/13-14 Immunology Devices Panel of the Medical Devices Advisory Committee mee...

Info Collection on FOIA Identity Form

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Federal Register notice: FDA seeks comments on an information collection extension for Certification of Identity; Form FDA 3975.

Info Collection for Device Shortage Data System

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection for Medical Devices; Shortages Data Collection System.