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Consider New Approach to Monitor Drug Quality

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University of Kentucky researchers say FDA should consider moving to an alternate approach to monitoring drug quality rather than ...

Last Minute Manufacturing Data Delays Novavax Vaccine

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FDA delays making a decision on Novavaxs Covid-19 vaccine emergency use authorization request after the company submitted last min...

End Patent Thickets: Senators

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A bipartisan group of six senators calls on the U.S. Patent and Trademark Office to change its policies and procedures to eliminat...

FDA Accepts Few Labeling Changes for Propecia

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FDA orders some Propecia labeling changes sought in a 2017 petition and denies most of the other changes sought.

House Passes User Fee/FDA Amendments Bill

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The U.S. House of Representatives votes 392 to 28 to pass the Food and Drug Amendments of 2022), which would reauthorize FDA user ...

GE Ventilator Backup Battery Class 1 Recall

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FDA sets a Class 1 designation on a recall of GE Healthcares ventilator batteries used in certain Carescape R860 Ventilators.

4 Advisory Committees Renewed for 2 Years

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Federal Register notices: FDA renews the charters for four advisory committees for an additional two years.

Info Collection on New Animal Drug Submissions

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Federal Register notice: FDA sends to OMB an information collection extension entitled New Animal Drug Applications and Veterinary...

Superior Response in Covid Omicron Booster: Moderna

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Moderna says its bivalent Covid vaccine booster specifically targeting the Omicron variant achieved superior antibody response aga...

Drug/Device User Interface MAPP

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CDER issues a MAPP outlining the roles and responsibilities of the Office of Generic Drugs and Office of Surveillance and Epidemio...