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FDA Withdrawing InvaGen Trandolapril ANDA

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Federal Register notice: FDA proposes to withdraw approval of an InvaGen Pharmaceuticals ANDA for trandolapril tablets.

FDA Regenerative Medicine Framework is Important Step: Pew

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A Pew Charitable Trusts report praises the FDA 2017 framework on regulation of regenerative medicine as a good first step and says...

Court Rejects Innovator Liability in Generic Drug Case

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Washington Legal Foundation reports on an Idaho state court decision that rejected the legal theory that a branded drug company ca...

Continuous Pharmaceutical Manufacturing Bill In

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Reps. Pallone and Guthrie introduce bipartisan legislation to allow FDA to partner with universities as National Centers of Excell...

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company PetNet Solutions.

HeartVista AI-assisted MRI Software Cleared

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FDA clears a HeartVista 510(k) to use its artificial intelligence-assisted One Click MRI acquisition software for cardiac exams.

OMB Clears 10 Information Collections

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Federal Register notice: FDA posts a list of FDA information collections recently approved by OMB.

FDA Alert Update on Endovascular Grafts

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FDA updates a 2018 safety alert about Endologixs AFX endovascular graft systems used in treating abdominal aortic aneurysms and th...

Public Meeting on Pediatric Study Requirements

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Federal Register notice: FDA announces an 11/21 public meeting seeking input on a report to Congress about pediatric study require...

Info Collection on Drug Maker Emergency Plans

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Federal Register notice: FDA seeks comments on an information collection extension entitled Planning for the Effects of High Absen...