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Regulatory Affairs

Home » Topics » Pharmaceuticals » Regulatory Affairs
  • January 31, 2023

    FDA Issues Draft Guidance on Developing Drugs for Treatment of Acromegaly

    Sponsors developing drugs for treating acromegaly should assess the relationship between doses and/or exposure-response based on insulin-like growth factor 1 (IGF-1) levels in early-phase trials, the FDA said in a draft guidance released Monday. 

  • January 31, 2023

    CBER Releases Guidance Agenda for 2023

    The FDA’s Center for Biologics Evaluation and Research (CBER) has released its guidance agenda for 2023, including five planned guidances on tissues and advanced therapies. 

  • January 31, 2023

    ICH Finalizes Revised Quality Risk Management Guideline

    The International Council for Harmonization (ICH) has issued the final version of its revised guideline on quality risk management ICH Q9(R1), adding information on risk management methodology, such as assessing the degree of risk analysis required, risk-based decision-making and managing subjectivity.

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  • January 31, 2023

    EMA Expert Panel Endorses Four New Medicines

  • January 31, 2023

    Senators Re-Introduce Bill to Create USPTO-FDA Task Force

  • January 30, 2023

    Sen. Warren Presses FTC to Scrutinize Two Pending Pharma Mergers

  • January 30, 2023

    FDA Pulls Evusheld EUA, But AstraZeneca Has Another Antibody in The Wings

  • January 30, 2023

    Senators Re-Introduce Bill to Create USPTO-FDA Task Force

  • January 27, 2023

    Texas Compounder Draws Warning Letter for Sterility Lapses

  • January 27, 2023

    NICE Recommends Yescarta for Certain Forms of Large B-Cell Lymphoma

  • January 27, 2023

    Syros Gets Fast Track Status for Higher-Risk Myelodysplastic Syndrome Candidate

  • January 27, 2023

    FDA Denies Petitions for CBD Rulemaking, Says Products Need New Regulatory Framework

  • January 27, 2023

    AdComm Recommends Combining Primary and Booster COVID Strains in One Annual Shot

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