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Consultants See Industry Gains in FDA Quality Plan

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Paragon Consulting says businesses that invest now in a quality approach that fits with the FDA Quality Metrics Initiative can rea...

CDRH Webinar Explains 2 De Novo Guidances

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A CDRH Webinar describes elements in one final guidance and one draft guidance relating to the de novo classification program.

Gottlieb Boosts New Drug Approvals, Continuous Mfg.

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FDA commissioner Scott Gottlieb assures Congress that the timely implementation of the 21st Century Cures Act is one of the agency...

Patients Should Benefit from Drug Discounts: PhRMA

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A PhRMA report traces how money moves through the pharmaceutical distribution system and suggests that patients should get more of...

Draft Guide on Dual 510(k) and CLIA Waiver

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Federal Register notice: FDA makes available a draft guidance entitled Recommendations for Dual 510(k) and Clinical Laboratory Imp...

Public Hearing on Evaluating Nicotine Replacement Products

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Federal Register notice: FDA announces a 1/26/2018 public hearing on its approach to evaluating the safety and efficacy of nicotin...

Webinar Stresses Streamlined Approach to Digital Health

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CDRH associate director for digital health Bakul Patel tells a webinar on precertification that the goal is a streamlined regulato...

FDA OKs Earhook Addition to Advanced Bionics Sound Processor

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FDA approves an Advanced Bionics PMA supplement to add an acoustic earhook for its the Nada CI Q90 sound processor that transforms...

FDA Worries More About Companies Than Patients: Professor

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Journalism professor Charles Seife details ways in which he says FDA is withholding information about Sareptas Exondys 51 to prote...

Regulatory Review Period Determined for Xuriden

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Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Wellstat Therapeutics Xurid...