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OMB OKs Info Collection on Postmarket Safety Reports

[ Price : $8.95]

Federal Register Notice: The Office of Management and Budget approves a collection of information on providing waiver-related mate...

OMB OKs Info Collection on Device Regulatory Misconduct

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Federal Register Notice: The Office of Management and Budget approves a information collection on electronic submission of allegat...

OMB OKs Info Collection on DTC Rx Drug Ad Viewing

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Federal Register Notice: The Office of Management and Budget approves a collection of information on eye tracking study of direct-...

FDA Withdraws 3 ANDAs with Propoxyphene

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Federal Register Notice: FDA withdraws approval of three ANDAs for products containing propoxyphene.

FDA Adds Info on Panel Meeting on Chantix

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Federal Register Notice: FDA amends the notice of a joint meeting advisory panel meeting to add information to the agenda, which w...

FDA Clears Medtronic Noncompliant Balloon Catheter

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FDA clears a Medtronic 510(k) for its NC Euphora Noncompliant Balloon Dilatation Catheter.

Market Forces Behind Drug Shortages: Policy Brief

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A Health Affairs policy brief examines drug shortages controversy and its link to underlying market forces as one of the primary c...

Courts Should Not Subvert Congress, FDA: WLF Paper

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Attorney John Park cautions that an Alabama Supreme Court decision in a generic drug failure-to-warn case could subvert congressio...

FDA Panel Endorses Novo Nordisks Liraglutide for Weight Management

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FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes 14 to 1 to recommend approval of a higher dose version of Novo No...

Comparative Ad Claims Can Mislead Consumers: Studies

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An FDA-funded study finds that comparisons made in drug DTC ads can mislead consumers about a drugs efficacy or risk.