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Guide on Study E-Records/Signatures

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Electronic Systems, Electronic Records, and Electronic Sig...

Augmentin Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that U.S. Antibiotics Augmentin XR (amoxicillin; clavulanate potassium) extended-release t...

FDA Fast Track for Volastra Ovarian Cancer Drug

[ Price : $8.95]

FDA grants fast-track designation to an investigational Volastra drug intended to treat some cases of ovarian cancer

Lab Groups Seek Summary Judgment in LDT Suit

[ Price : $8.95]

Two trade associations that oppose FDA regulation of laboratory-developed tests ask a Texas federal court to grant summary judgmen...

Stem Cell Company CEO Gets 36 Months in Jail

[ Price : $8.95]

The Justice Department says Liveyon founder and CEO John Kosolcharoen has been sentenced to 36 months in prison after pleading gui...

Fresenius Recalls Ivenix Infusion Pump Software

[ Price : $8.95]

Fresenius Kabi recalls (Class 1 device correction) its Ivenix Infusion System Large Volume Pump software due to multiple software ...

Panel to Review Andexxa sBLA

[ Price : $8.95]

Federal Register notice: FDA announces an 11/21 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to review an Astra...

Lexicon Diabetes Drug Heads to Panel

[ Price : $8.95]

Federal Register notice: FDA announces that a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting will review a Le...

Trial Electronic Systems, Records, Signatures Guide

[ Price : $8.95]

FDA publishes a guidance with questions and answers on using electronic systems, records, and signatures in clinical investigation...

13 Observations in ProRx FDA-483

[ Price : $8.95]

FDA releases the form FDA-483 with 13 observations from an inspection at the Exton, PA-based ProRx drug outsourcing facility.