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PhRMA Suggests REMS Standardization Changes

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PhRMA suggests ways FDA can improve its efforts to standardize REMS.

Petition Wants Additional Cefdinir RLD

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Hyman, Phelps & McNamara asks FDA to designate one of four ANDA-approved companies making cefdinir for oral suspension as a second...

Multiple Violations Found at Y.S. Health

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FDAs Chicago District Office warns Y.S. Health about violations of dietary supplement CGMP regulations as well as distributing una...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Brower Enterprises, Gum Runners, and Y.S. Health.

FDA Grants Arzerra Breakthrough Status

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FDA grants Genmab and GlaxoSmithKline a breakthrough therapy designation for Arzerra (ofatumumab) in combination with chlorambucil...

Hospira Recalls Bupovacaine Due to Particulates

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Hospira recalls one lot of 0.25% bupivacaine HCl Injection, USP (2.5 mg/mL), 30 mL single-dose vials due to the presence of partic...

FDA Slaps Ranbaxy with Consent Decree Terms at Another Facility

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FDA places another Ranbaxy drug manufacturing plant in India under terms of a 2012 consent decree after two inspections last year ...

Blood Panel to Discuss MP Biomedicals BLA

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Federal Register Notice: FDAs Blood Products Advisory Committee will meet 11/1 to discuss MP Biomedicals BLA for a Western blot in...

FDA Clears Vital Access Vascular Needle Guide

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FDA clears a Vital Access Corp. 510(k) for its Vwing Vascular Needle Guide for patients undergoing dialysis.

FDA Approves Suns Generic Prevacid

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FDA approves a Sun Pharmaceutical Industries ANDA for a generic version of Prevacid (lansoprazole) delayed-release capsules USP, 1...