RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Please see our Privacy Policy for more information.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

29 May 2020
Some extended-release formulations of the diabetes drug metformin contained levels of a nitrosamine impurity falling above the US Food and Drug Administration’s (FDA’s) acceptable intake limit, according to recent testing conducted by the agency.

Latest News

ALL
29 May 2020
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.
29 May 2020
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...
29 May 2020
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.
29 May 2020
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 ...
29 May 2020
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).
28 May 2020
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...