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 questions ...

  • 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 a ...

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  • The US Food and Drug Administration has issued draft guidance, Identifying Trading Partners Under the Drug Supply Chain ...

  • The US Food and Drug Administration (FDA) has issued draft guidance, CMC Postapproval Manufacturing Changes for Specified ...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

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

  • The US Food and Drug Administration (FDA) has announced its intent to establish a pilot-project program under the Drug Supply ...

  • Following the passage in the US House of Representatives of a bill that would reauthorize user fees for prescription drugs, ...

  • The US Food and Drug Administration (FDA) Commissioner Scott Gottlieb highlighted the staffing priorities at the agency and ...

  • The US Food and Drug Administration (FDA) has provided details of the implementation of the 21st Century Cures Act , which ...

  • The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) are stepping up ...

  • The US Food and Drug Administration (FDA) has issued draft guidance, Product Identifier Requirements Under the Drug Supply ...

  • The US Food and Drug Administration (FDA) has unveiled a strategic plan to eliminate the agency’s existing orphan designation ...

  • The European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents the pharmaceutical industry ...

  • Among the decisions made at its most recent meeting held May 27 to June 1, 2017 in Montreal, Canada, the International Council ...