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Final Rule on DTC Ads Major Statements

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A new final rule outlines five standards that the agency says drug marketers must follow to ensure their direct-to-consumer advert...

Bayer Stops Stroke Drug Study Over Inferiority

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Bayer stops its Phase 3 OCEANIC-AF study evaluating asundexian compared to apixaban (Bristol-Myers Squibbs Eliquis) in patients wi...

FDA Warns on Monoject Syringes

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FDA warns healthcare professionals not to use Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesi...

Janssen Seeks Expanded Rybrevant Use

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Janssen Pharmaceutical files a supplemental BLA for Rybrevant (amivantamab-vmjw) in combination with chemotherapy (carboplatin and...

Dr. Reddys Issued 10-item FDA-483

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FDA issues Dr. Reddys Laboratories a 10-item Form FDA-483 after an inspection 10/27 at the firms Telangana, India manufacturing fa...

Device Discontinuance Notification Guides

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Federal Register notice: FDA makes available a final guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption...

Panel to Discuss 506J Device List

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Federal Register notice: FDA announces a 2/6/2024 advisory committee meeting on medical device supply chain resiliency and shortag...

Final Guide on Device Computational Modeling

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Federal Register notice: FDA makes available a final guidance entitled Assessing the Credibility of Computational Modeling and Sim...

FDA OKs AstraZeneca Breast Cancer Drug

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FDA approves an AstraZeneca NDA for Truqap (capivasertib) for use with fulvestrant in certain adult patients with hormone receptor...

Mercks Keytruda Gains OK in Gastric Cancer

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FDA approves a Merck NDA for Keytruda (pembrolizumab) and its use with fluoropyrimidine- and platinum-containing chemotherapy for ...