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CGMP Violations at Chinas Hubei Pharmaceutical Co.

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FDA warns Chinas Hubei Pharmaceutical Co. about CGMP violations in its production of active pharmaceutical ingredients.

Genentech Sues Pfizer Over Herceptin Patents

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Genentech says a Pfizer biosimilar to its Herceptin will infringe 40 Genentech patents and should be barred by a federal court inj...

White House Puts 2015 Opioid Crisis Cost at $500 Billion

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A new White House report estimates that the ongoing opioid crisis cost the U.S. $504 billion in 2015 and led to over 33,000 Americ...

Janssen Biosimilar Patent Infringement Complaint Filed

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Federal Register notice: FDA acknowledges that an applicant for a proposed biosimilar product notified the agency that a patent in...

Guide on UDI Direct Device Markings

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Federal Register notice: FDA makes available a guidance entitled Unique Device Identification: Direct Marking of Devices.

FDA Approves Kalos AUVI-Q for Infants

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FDA approves a Kalo supplemental NDA for AUVI-Q (epinephrine injection, USP) 0.1 mg, for treating life-threatening allergic reacti...

Breakthrough, Orphan Drug Status for PellePharm Drug

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FDA grants PellePharm a breakthrough therapy designation and orphan drug designation for topical patidegib for patients with Gorli...

Medtronic Azure Pacemakers with BlueSync Approved

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FDA approves a Medtronic PMA for its Azure pacemakers with BlueSync technology.

Comments Extended on Cardiac Troponin Assays

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Federal Register notice: FDA extends its comment period provided in a 7/31 Federal Register notice entitled Cardiac Troponin Assay...

Comments Sought on Petition for OTC Denture Repair Kits

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Federal Register notice: FDA seeks comments on a petition from an undisclosed applicant requesting exemption from premarket notifi...