USA – FDA approves second over-the-counter naloxone nasal spray for opioid overdose
The FDA’s decision means that RiVive stands as the second non-prescription, OTC naloxone nasal spray product that the agency has approved.
FDA commissioner, Robert Califf,...
USA – Pharmaceutical distributors seek two-year delay in DSCSA tracking rules
Pharmaceutical distributors are calling for the US Food and Drug Administration (FDA) to grant a two-year delay enforcing the pharmaceutical tracking provisions of the Drug...
International – FDA announces completion of first joint assessment with EMA in ICMRA pilot
The US Food and Drug Administration (FDA) on Friday announced the completion of its first collaborative assessment of a post-approval change for an oncology...
USA – Labeling, DTC advertising and compounding rules make FDA’s semiannual regulatory agenda
The US Department of Health and Human Services (HHS) has published its semiannual regulatory agenda that includes rules the Food and Drug Administration (FDA)...
USA – FDA finalizes guidance on drug quality consensus standards recognition program
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Wednesday published a final guidance on its process for...
Europe – Paving the way towards coordinated clinical trials in public health emergencies in...
EMA has published a report from a workshop that collected insights and suggestions for possible EU-level actions to improve the way clinical trials are set...
International – WHO proposes best practices for clinical trials
The World Health Organization (WHO) has issued a draft guidance spelling out some of the important scientific and ethical considerations for well-designed clinical trials....
Europe – Review: real-world data studies
Sustainable framework to support scientific evaluations in the EU
By complementing existing evidence, use of real-world data (RWD) and real-world evidence (RWE) can speed up...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
14 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its July 2023 meeting.
The CHMP recommended granting a marketing authorisation for Abrysvo (bivalent, recombinant),...
Europe – First RSV vaccine to protect infants up to 6 months of age...
EMA has recommended granting a marketing authorisation in the European Union (EU) for Abrysvo, a vaccine to protect against disease caused by the respiratory syncytial virus (RSV)....
