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GMPs

Home » Topics » Pharmaceuticals » GMPs
  • May 26, 2022

    Verrica Draws Second Complete Response Letter for Manufacturing Deficiencies

    West Chester, Pa.-based Verrica Pharmaceuticals drew a second Complete Response Letter (CRL) from the FDA rejecting the company’s New Drug Application (NDA) for its investigational drug VP-102 to treat patients with the viral skin disease molluscum contagiosum.
  • April 27, 2022

    Sanofi Teams Up With Racing Team McLaren to Speed Up Manufacturing

    The two partners already worked together in 2021 in a pilot format.
  • April 11, 2022

    Bayer to Inject More Than $2 Billion Into Upgrading Manufacturing

    The company will spend more than $1 billion on several of its German manufacturing centers. 
Read More
  • July 6, 2020

    FDA Outlines GMPs for COVID-19 Infections in Workers

  • July 6, 2020

    USP Supports Use of Crab-Derived Reagents for Drug Tests

  • June 22, 2020

    FDA Outlines GMPs for Drugmakers Dealing With COVID-19 Infections in Workers

  • June 5, 2020

    USP Supports Continued Use of Crab-Derived Reagents for Drug Tests

  • April 17, 2020

    FDA Eases Requirements for Some Compounded COVID-19 Drugs

  • September 26, 2018

    FDA Warns Indian OTC Facility for Quality Violations

  • September 25, 2018

    FDA Warns Indian OTC Facility for Quality Violations

  • February 15, 2018

    FDA to Define GMPs for Outsourcing Facilities

  • December 19, 2017

    European Commission Issues New GMP Guidelines for Advanced Therapies

  • December 11, 2017

    Morrison Says ORA Reorganization Will Mean More Foreign Inspections

Read More

Products

  • John e lincoln 600green

    Pharmaceutical Process Validation: Best Practices for Success – Webinar Recording/Transcript

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    Gene & Cell Therapy Regulation: Comparability and Other New Developments – Webinar Recording/Transcript

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    Is Your Product a Drug or Device — and Does It Matter?: A Recent Appeals Court Decision Says It Does – Webinar Recording/Transcript

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  • Richard kingston and diane mcenroe 600red

    Recall Readiness: Dust Off Your SOPs, There’s a New Guidance in Town – Webinar Recording/Transcript

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Events

  • 28Jul

    Is Your Product a Drug or Device — and Does It Matter?: A Recent Appeals Court Decision Says It Does

  • 03Aug

    Pharmaceutical Process Validation: Best Practices for Success

  • 10Aug

    Gene & Cell Therapy Regulation: Comparability and Other New Developments

More
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