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Comments Sought on Exporting Unapproved Devices

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on reporting for firms intending to export unapproved devices.

Comments Sought on Mammography Standards

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Federal Register Notice: FDA solicits comments reporting and recordkeeping associated with the Mammography Quality Standards Act.

Industry Says Device User Fees Not Working

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Device manufacturers say FDA and Congress hasnt provided the improved service promised in return for user fees.

FDA Sends Info on Animal Drug Experiences to OMB

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Federal Register Notice: FDA sends a proposed collection of information on records and reports of experiences with approved new an...

Environmental Impact Info Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on environmental impact considerations to the Office of Ma...

Public Meeting on Device Identification

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Federal Register Notice: FDA plans a public meeting and vendor display 10/25 in Gaithersburg, MD on developing a unique identifica...

FDA OKs Alcons BAK-free Travatan Z for IOP

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FDA approves Alcons Travatan Z 0.004%, a benzalkonium-chloride-free formulation, for reducing elevated intraocular pressure in cer...

Latest FDA-483s, EIRs, etc. Received from FDA

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We post our latest FDA-483s, EIRs, correspondence, etc. received from FDA for American IV Products, American Red Cross Diagnostic ...

Illinois Official Says Rx Import Program Illegal

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The Illinois auditor general says the states prescription drug import program has been used by very few people and violates federa...

Alexion Pharmaceuticals BLA Filed for Soliris

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Alexion Pharmaceuticals submits a BLA for Soliris (eculizumab) as a treatment for patients with paroxysmal nocturnal hemoglobinuri...