REGULATORY NEWS

REGULATORY NEWS

  • The Subcommittee on Health of the US House of Representatives’ House Energy & Commerce Committee held a hearing to examine ...

  • The International Council for Harmonization (ICH) moved forward a questions-and-answers (Q&A) guideline to help clarify ...

  • The US Food and Drug Administration (FDA) is inviting input through a public docket, open until September 21, 2017, on issues ...

  • Scott Gottlieb, MD, Commissioner of the US Food and Drug Administration (FDA), outlined the steps that the agency is taking ...

  • FDA Sets GDUFA Fees for FY 2018

    The US Food and Drug Administration (FDA) has set fiscal year (FY) 2018 rates for the Generic Drug User Fee Amendments (GDUFA) ...

  • The US Food and Drug Administration (FDA), the European Commission, and the European Medicines Agency (EMA) have signed ...

  • President Donald Trump has signed into law the FDA Reauthorization Act of 2017 , which reauthorizes the US Food and Drug ...

  • The US Food and Drug Administration has issued draft guidance, Identifying Trading Partners Under the Drug Supply Chain ...

  • The US Food and Drug Administration (FDA) has issued draft guidance, CMC Postapproval Manufacturing Changes for Specified ...

  • The US Senate has voted to pass The FDA Reauthorization Act, which reauthorizes user fees for prescription drugs, generic ...

  • The US Senate voted to pass The FDA Reauthorization Act, which reauthorizes user fees for prescription drugs, generic ...

  • The US Food and Drug Administration (FDA) has released draft goals and procedures for a potential user fee program for nonprescription ...