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Proposal to Add 3 Drugs to Withdrawn List for Compounding Ban

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Federal Register Notice: FDA proposes to amend its regulations to add three drugs to the list of drug products that have been with...

Class 2 Designation for Upper Extremity Prosthesis

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Federal Register Final Order: FDA classifies as Class 2 (special controls) the upper extremity prosthesis including a simultaneous...

Proposed Rule on Home-use Device e-Submissions

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Federal Register proposed rule: FDA proposes to implement provisions requiring electronic submission of the device label and packa...

FDA Classifies Apical Closure Devices as Class 2

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Federal Register Final Order: FDA classifies the apical closure device into Class 2 (special controls).

Cancer Moonshot Report Highlights Strategic Goals

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President Obamas Cancer Moonshot initiative releases a task force report on implementation plans.

FDA Clears Teleflex Arrow Midline Antimicrobial Catheter

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FDA clears a Teleflex 510(k) to market its Arrow Midline with Chlorag+ard Technology, an anti-thrombogenic and antimicrobial perip...

Sandoz Seeks Stricter Advair Bioequivalence in ANDAs

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Sandoz petitions FDA asking that it not approve generic copies of GlaxoSmithKlines asthma inhaler Advair Diskus 100/50 unless ANDA...

FDA Reviewers Question Trial Designs with Nocturia Drug

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FDA reviewers question clinical trial designs in a Serenity Pharmaceuticals NDA for SER120 (desmopressin nasal spray), which is pr...

Omnicare Pays $28 Million to Resolve Abbott Kickback Probe

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Omnicare agrees to pay $28 million to resolve allegations that it solicited and received kickbacks from Abbott Laboratories in exc...

Guide on ANDA Prior Approval Supplements

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Federal Register Notice: FDA makes available a guidance on ANDA Submissions Prior Approval Supplements Under GDUFA.