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FDA Clears New Bausch & Lomb Lenses

[ Price : $8.95]

FDA clears a Bausch & Lomb 510(k) for its newest frequent replacement silicone hydrogel contact lenses made with MoistureSeal Tech...

UDI Implementation Will Be a Challenge: Lawyer

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Attorney John Smith looks at problems some companies will face in implementing FDAs new medical device tracking requirements.

FDA Approves Lupin Generic Zymaxid

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FDA approves a Lupin ANDA for a generic copy of Allergans Zymaxid (gatifloxacin) ophthalmic solution.

FDA Announces 10 New, Updated Medication Guides

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FDA releases 10 new or updated Medication Guides.

Generic Drug RTR Letters Likely to Increase: Consultant

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Lachman Consultants Bob Pollock says the Office of Generic Drugs is likely to refuse to accept more ANDAs under requirements in a ...

Scheduled Advisory Committees Still On During Government Shutdown

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FDA honors scheduled advisory committee meetings during the current government shutdown.

Electronic Application Form Oversight MAPP Out

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CDER issues an electronic application form oversight MAPP.

Wyeth Menopause Drug Approved by FDA

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FDA approves a Wyeth Pharmaceuticals NDA for Duavee (conjugated estrogens/bazedoxifene) for women who suffer from moderate-to-seve...

Hypercholesterolemia Study Positive for Alnylam Drug

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Alnylam Pharmaceuticals reports positive Phase 1 study results of its ALN-PCS RNAi drug targeting PCSK9 for treating hypercholeste...

FDA Clears Nucletron Brachytherapy System for Skin Cancer

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FDA clears a Nucletron 510(k) for Esteya, an electronic brachytherapy system for treating skin cancer.