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Regulatory Affairs

Home » Topics » Pharmaceuticals » Regulatory Affairs
  • May 20, 2022

    CanSino Biologics’ COVID-19 Vaccine Gets EUL From the WHO

    The WHO is recommending the vaccine for people age 18 years and older.
  • May 20, 2022

    Maine Joins Two Other States Considering Making Their Own Insulin

    The commission will also examine the feasibility of providing the state-produced insulin to low-income residents.
  • May 20, 2022

    Roche’s Faricimab Gains UK Approval Via International Program

    The approval is the first MHRA granted under the collaborative program.
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  • May 20, 2022

    States, Medical Groups File Briefs Supporting HHS in Legal Battle Over 340B Drug Discount Program

  • May 20, 2022

    CDC Panel Recommends Booster Doses in Children Age Five to 11

  • May 20, 2022

    House Subcommittee Quizzes Califf on New Role for Woodcock, Status of Foreign Inspections in Budget Hearing

  • May 20, 2022

    PhRMA Wins as Federal Judge Tosses Out 2020 Medicaid ‘Best Price’ Requirement

  • May 19, 2022

    FDA Extends Shelf-Life of Sotrovimab to 18 Months

  • May 19, 2022

    Use of Pfizer’s Paxlovid Spikes by 315 Percent

  • May 19, 2022

    Asthma Drug Developers Obstructed Generics, Study Finds

  • May 19, 2022

    Surrogate Endpoints, Fewer Trials Continue to Back Novel Drug Approvals

  • May 19, 2022

    Focus Label Design on Preventing Medication Errors, FDA Final Guidance Tells Drugmakers

  • May 19, 2022

    Senate Committee Releases Draft User Fee Bill as House Votes to Send Its Version to the Floor

Read More

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    FDA’s New Distributor Licensing Standards – Webinar Recording/Transcript

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    Supply-Chain Solutions: Managing Demand and Logistics in a Postpandemic World

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Events

  • 24May

    Quality Culture: You Can’t Improve What You Don’t Measure — Practical, Innovative Diagnostic Tool Allows Companies to Measure and Improve Their Quality Culture

  • 09Jun

    How to Standardize your Lab Investigation Process: Increase Efficiency and Reduce Risk with a Consistent Process

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

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