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FDA Orphan Status for TG Therapeutics Leukemia Therapy

[ Price : $8.95]

FDA grants TG Therapeutics an orphan drug designation for its next generation PI3K Delta inhibitor, TGR-1202, for treating patient...

FDA Clears Bio2 Medical Angel Catheter

[ Price : $8.95]

FDA clears a Bio2 Medical 510(k) for the Angel Catheter, intended for use in preventing pulmonary embolism in patients who cannot ...

FDA Revamps Minor Species Reg for Animal Drugs

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FDA announces a direct final rule intended to ensure that antimicrobial drugs used in animal feed remain available for therapeutic...

Galapagos, Gilead Launch Phase 3 Program for Arthritis Drug

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Galapagos and Gilead begin a Phase 3 clinical trial program called FINCH that will investigate the efficacy and safety of 100 mg a...

CGMP Violations in 2 Unimark Facilities

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FDA warns Unimark Remedies about CGMP violations at two active pharmaceutical ingredient manufacturing facilities in India.

FDA, Device Industry Agree to $400 Million Jump in User Fees

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FDA and the medical device industry reach an agreement in principle on the next round of user fees that will see fees skyrocket by...

FDA Issues Patient Preference Info Guidance

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FDA issues a guidance with concepts for sponsors and stakeholders to consider when choosing to collect and submit patient preferen...

FDA Proposing GLP Quality System

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FDA proposes regulatory changes to implement a Good Laboratory Practice Quality System to help ensure the quality and integrity of...

QS Problems Found at Tosoh Bioscience

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FDAs Cincinnati District Office warns Tosoh Bioscience about multiple Quality System regulation violations at its Grove City, OH, ...

General Support for Draft PDUFA 6 Letter

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Stakeholders voice general support for a PDUFA 6 commitment letter circulated by FDA for comments.