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Comments on Therapeutic Protein Guidance

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Two stakeholders give FDA recommendations on a draft guidance on assessing drug-drug interactions in therapeutic proteins.

Info Collection for In Vivo Radiopharmaceuticals

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Federal Register notice: FDA seeks comments on an information collection extension for Regulations for In Vivo Radiopharmaceutical...

OMB Approves 7 FDA Information Collections

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Federal Register notice: FDA has published a list of seven information collections that have been approved by OMB.

Pfizer Says Positive Results in Abrocitinib Study

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Pfizer says its investigational atopic dermatitis drug abrocitinib met its primary and key secondary endpoints in the Phase 3 JADE...

Senate Spending Bill has $50 Million Boost for FDA

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A U.S. Senate Appropriations Committee-released bill for fiscal year 2021 proposes $3.21 billion in discretionary funding for FDA,...

FDA Authorizes NightWare Platform Marketing

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FDA gives de novo marketing authorization to the NightWare therapeutic platform to interrupt PTSD-associated nightmares.

Sebela Pharma Sutab Tablets OKd for Colon Prep

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FDA approves a Sebela Pharmaceuticals NDA for Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) tablets, indicated...

FDA Fast Track for Surface Oncology Liver Cancer Drug

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FDA gives fast track designation to Surface Oncologys SRF 388 investigational liver cancer drug.

Nanowears SimpleSense Undergarment Monitor Cleared

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FDA clears a Nanowear 510(k) for its cloth-based diagnostic platform SimpleSense, a multi-parameter remote diagnostic undergarment...

Lilly Gets EUA for Covid Antibody Treatment

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FDA grants Eli Lilly an emergency use authorization for its investigational monoclonal antibody therapy bamlanivimab for treating ...