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FDA Clears Bolton Medical Relay Stent Graft

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FDA clears a Bolton Medical Relay thoracic aorta stent.

Vantas Caregiver Brochure Omits Risk Informatio: OPDP

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CDERs Office of Prescription Drug Promotion says that an Endo caregiver brochure downplays significant risks associated with Vanta...

Depomed Sues FDA Over Gralise Non-Orphan Exclusivity

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Depomed sues FDA over the agencys refusal to grant Orphan Drug exclusivity to its drug, Gralise (gabapentin), and its use in manag...

FDAs Skin Wash Designation Arbitrary and Capricious: Court

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DC federal court judge Rosemary Collyer faults FDA for its determination that Prevors skin wash product is a combination product w...

Advisors Asked if Retinal Prosthesis is Safe, Effective

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FDA asks members of its Ophthalmic Devices Panel whether a retinal prosthesis is likely to be safe and effective in inducing visua...

FDA Approves REMS for Mycophenolate Drugs

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FDA approves a REMS including a pregnancy registry for all mycophenolate-containing drugs.

Device-related Key Issues Under FDASIA: Blog

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A Hyman Phelps & McNamara blog posting summarizes key provisions CDRH is working on after the passage of the FDA Safety and Innova...

Pfizer Wants Generic Oxecta ANDA Restrictions

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Pfizer asks FDA to require applicants for generic Oxecta to use the same inactive ingredients that contribute to its safety profil...

Comments Extended on Antimicrobial New Animal Drugs

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Federal Register Advance notice of proposed rulemaking: FDA extends the comment period on potential changes to its regulations for...

FDA Commissioner Delegated Authority on Clinical Trial Info

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Federal Register Notice: The HHS Secretary delegates authority to the FDA commissioner to determine that any clinical trial inform...