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 ...
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The US Food and Drug Administration has issued draft guidance, Identifying Trading Partners Under the Drug Supply Chain ...
The US Food and Drug Administration (FDA) has issued draft guidance, CMC Postapproval Manufacturing Changes for Specified ...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The US Food and Drug Administration (FDA) has issued draft guidance, Product Identifier Requirements Under the Drug Supply ...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 ...