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ANDA Sameness Evaluation Guidance

[ Price : $8.95]

FDA publishes a draft guidance with recommendations on how ANDA applicants can demonstrate sameness between the active ingredient ...

FDA Raises Sabizabulin Uncertainties

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FDA raises uncertainties with Verus request for Covid-19 treatment emergency use authorization for its repurposed investigational ...

Omeros Loses Appeal on Stem Cell Transplant Drug

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CDERs Office of New Drugs denies an Omeros appeal of complete response letter on its BLA for narsoplimab as a treatment for hemato...

Review Period for AngelMed Guardian System

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Angel Medical Systems Angel...

Drug-Device Combo Firms Quiz FDA on Specs

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The Combination Products Coalition says its members have several concerns with recent FDA requests for validation of product inter...

Nourianz Regulatory Review Period

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Kyowa Kirins Nourianz (istr...

Start Device Covid Transition Plans Now: Attorneys

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Two Wiley Rein attorneys caution medical device manufacturers to start preparing their transition plans and marketing applications...

FDA Seeks New Accelerated Approval Requirement

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FDA appears to be raising the bar for sponsors seeking accelerated approval by requesting that they be well underway with their Ph...

Libtayo +Chemo Approved for Advanced Lung Cancer

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FDA approves Regeneron Pharmaceuticals PD-1 inhibitor Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy fo...

7 Combination Product Guidances on the Way

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Office of Combination Products director Thinh Nguyen says seven draft and final guidances affecting combination products should be...