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Immunotoxic Potential Draft Guidance Out

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FDA publishes a draft guidance to help sponsors of some products regulated by CDER and CBER perform nonclinical safety evaluations...

Ex-FDA Lawyer McConagha Moves to Skadden

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Former FDA attorney William McConagha moves from Sidley Austin to Skadden, Arps, Slate, Meagher & Flom as health care litigation a...

Panel to Review Glaxo Trelegy Ellipta sNDA

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Federal Register notice: FDA announces a 4/21 Pulmonary-Allergy Drugs Advisory Committee meeting to discuss a GlaxoSmithKline supp...

Medical Imaging Panel to Review Alzheimers Diagnostic

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Federal Register notice: FDA announces a 4/23 Medical Imaging Drugs Advisory Committee meeting to review an Avid Radiopharmaceutic...

FDA Denies Methscopolamine Petition

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FDA denies a petition asking it to require compliance with a guidance and taken enforcement action against non-compliant manufactu...

Merck sBLA on Keytruda Dosing Option Rejected

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FDA issues Merck a complete response letter on a supplemental BLA seeking to update the dosing frequency for Keytruda (pembrolizum...

ResMed Recalls Stellar 100 & 150 Ventilators

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ResMed recalls its Stellar 100 and 150 Non-invasive and Invasive Ventilators due to a sound alarm failure.

FDA Issues EIR for Aurobindo Pashamylaram Unit 4

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FDA issues an Establishment Inspection Report to Aurobindo Pharma for its Pashamylaram Unit 4 injectable manufacturing facility.

More than 1,000 ANDAs Approved in 2019

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Office of Generic Drugs director Sally Choe says more than 1,000 ANDAs were given final or tentative approval in 2019.

Abbott Vascular Dilation Catheter Recall is Class 1

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FDA says an Abbott Vascular recall of specific lots of coronary dilation catheters due to a balloon issue is Class 1.