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Comments Extended on Drug Shortages Guide

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Federal Register notice: FDA extends the comment period on a draft guidance entitled Risk Management Plans to Mitigate the Potenti...

Elite Supplement Center Illegally Selling SARM Products: FDA

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FDA warns Elite Supplement Center that it is illegally marketing selective androgen receptor modulator products that are legally c...

Byondis BLA for Breast Cancer Therapy Accepted

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FDA accepts for review a Byondis BLA for SYD985 ([vic-] trastuzumab duocarmazine) for use in patients with HER2-positive unresecta...

FDA Authorizes Watmind At-Home Covid Antigen Test

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FDA grants an emergency use authorization to Watmind USA for its over-the-counter at-home Covid-19 antigen test.

Fresenius Propoven 2% Emulsion Authorization Revoked

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Federal Register notice: FDA revokes an Emergency Use Authorization issued to Fresenius Kabi USA for its Fresenius Propoven 2% Emu...

31 No-Longer-Marketed ANDAs Withdrawn

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Federal Register notice: FDA withdraws approval of 31 ANDAs from multiple applicants because the products are no longer marketed.

FDA Slow to Inspect Monkeypox Vaccine Facility: Article

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A New York Magazine investigative report says FDA is partly responsible for delays in getting sufficient monkeypox vaccine doses i...

Abbott Deep Brain Depression Device is Breakthrough Device

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FDA grants breakthrough device designation to the Abbott deep brain stimulation system for use in treatment-resistant depression.

Getinge USA Anesthesia System Recall is Class 1

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FDA says a Getinge USA anesthesia system recall due to cracked or broken suction power switches is Class 1.

Mylan Recalls 1 Batch of Insulin Pens

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Mylan recalls one batch of unbranded insulin glargine pens due to the potential for some pens to be missing the label.