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UDI Small Entity Compliance Guidance

[ Price : $8.95]

FDA publishes a guidance to help small medical device companies comply with the unique device identification system regulation.

AdvaMed Gravely Concerned About Classification Proposal

[ Price : $8.95]

AdvaMed tells FDA it is gravely concerned about implications of the agencys proposed revised regulations on the classification and...

Senator Wants More FDA Action on Drug Shortages

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Senator Charles E. Schumer (D-NY) urges FDA to investigate and address a potential nationwide shortage of doxycycline.

FDA Approves Schedule IV Merck Insomnia Drug

[ Price : $8.95]

FDA approves a Merck NDA for Belsomra (suvorexant) tablets for treating insomnia.

From Anti-FDA Activist to FDA Supporter

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The Associated Press says the former AIDS activist Gregg Gonsalves who helped push FDA to provide faster reviews on HIV drugs is n...

ProTech Product Changed After 510(k): FDA Inspection

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FDAs Florida District Office warns ProTech Professional Products about 510(k) and Quality System violations in its works as a medi...

Appeals Court Decision Raises Petition Questions

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Attorney Robert Magielnicki says a recent appeals court dissent argues that the court majority went too far in seeing possible sha...

FDA Approves PMA for Colorectal Screening Test

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FDA approves an Exact Sciences PMA for Cologuard, the first stool-based colorectal screening test that detects the presence of red...

FDA Grants HDE for Lung Preservation System

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FDA grants Xvivo Perfusion a Humanitarian Device Exemption to market its Xvivo Perfusion System (XPS) with STEEN Solution, a devic...

Careful Public Disclosure of Interim Trial Data Possible, PhRMA Says

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PhRMA cautions FDA on public disclosure of detailed interim data from diabetes drug cardiovascular risk assessment analyses.