To further the establishment of a rare disease clinical trials network, the US Food and Drug Administration (FDA) is asking for input from the public and a broad array of stakeholders.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is recommending the authorization of eight new medicines, including a new vaccine against Ebola virus, and says it is waiting for Gilead Sciences to submit...

Regulatory Focus interviewed the FDA's Barbara Cohen, the first author of an agency-led labeling study, to learn more about the study and FDA’s efforts to facilitate the availability of OTC naloxone.

Nearly 40 years after its creation, the US Food and Drug Administration (FDA) is looking to modernize its Orange Book , which lists patent, exclusivity and therapeutic equivalence information for approved drugs, as part of its effort to increase ...

The US Food and Drug Administration (FDA) on Friday released a new emergency use authorization (EUA) template to assist test makers in developing at-home sample collection kits for use with tests for coronavirus disease (COVID-19).

The European Medicines Agency (EMA) and its counterparts at the European Commission and Heads of Medicines Agencies have updated their questions and answers guidance on regulatory expectations for medicinal products amid the coronavirus disease (C...