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Attorney Sues FDA to Keep Name Off FDA-483

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An attorney who works for a company regulated by FDA asks the DC federal court to stop the agency from publishing the attorneys na...

Regulatory Review Period for Ciplas Zemdri

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Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for Cipla USAs Zemdri (pla...

Viking Reports Positive Data on NASH Drug

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Viking Therapeutics provides encouraging top-line data from its Phase 2b clinical trial of VK2809 in patients with biopsy-confirme...

Judge Hits Precision Lens with $487 Million Fine

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A Minnesota federal judge enters a $487 million judgment against Cameron-Ehlen Group, which does business as Precision Lens, for v...

Abbott Spinal Stimulation Devices OK for Back Pain

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FDA approves an expanded indication for Abbott spinal cord stimulation (SCS) devices treating chronic back pain in those who have...

Comments on Electronic Systems Q&A Draft

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Five stakeholders comment on an FDA question-and-answer draft guidance on using electronic systems, records, and signatures in cli...

Pharmedica CGMP Violations Result in Plant Shutdown

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Phoenix, AZ-based Pharmedica USA tells FDA it will stop all drug production and distribution after the agency finds CGMP violation...

Tack Endovascular Device Regulatory Review Period

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Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for Intact Vasculars Tack ...

Ipca Laboratories FDA-483

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FDA releases the form FDA-483 with three observations issued following an April inspection at the Ipca Laboratories drug manufactu...

FDA Issues with Sea-Long Medical Treatment Hoods

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FDA warns Waxahachie, TX-based Sea-Long Medical Systems about multiple Quality System regulation violations in its production of m...