USA – FDA finalizes guidance on REMS format and content
The US Food and Drug Administration (FDA) on Wednesday finalized guidance outlining its expectations for the format and content of a risk evaluation and...
USA – FDA revises ANDA facility correspondence draft guidance
The US Food and Drug Administration (FDA) on Friday revised its draft guidance on submitting pre-submission facility correspondence (PFC) for generic drug applicants seeking...
Europe – Single-arm trials as pivotal evidence for the authorisation of medicines in the...
EMA has opened a public consultation on a reflection paper that discusses key concepts for single-arm clinical trials that are submitted as pivotal evidence in support of marketing authorisation...
UK – Kite’s CAR-T therapies recommended by NICE for certain blood cancers
The treatments, both given as one-off infusions, have been specifically recommended for use within the Cancer Drugs Fund (CDF), which pays for cancer treatments...
USA – FDA issues draft guidance on developing migraine prevention drugs
The US Food and Drug Administration (FDA) on Thursday released a draft guidance to help sponsors develop drugs to prevent migraines that offers recommendations...
USA – QMSR: Start now to be ready for final rule, slated for December
The US Food and Drug Administration (FDA) asserts that it is on track to release a final rule this December that harmonizes the agency’s decades-old Quality...
Europe – New medicine to protect babies and infants from respiratory syncytial virus (RSV)...
EMA has recommended a marketing authorisation in the European Union (EU) for Beyfortus (nirsevimab) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease...
UK – NICE publishes draft guidance recommending three COVID-19 treatments
The treatments recommended by NICE are Roche’s RoActemra (tocilizumab) and Eli Lilly’s Olumiant (baricitinib), both indicated for use in a hospitalised setting in patients...
Europe – EMA recommends approval of second adapted Spikevax vaccine
EMA’s human medicines committee (CHMP) has recommended authorising an adapted Spikevax COVID-19 vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the...
Europe – Regulatory information – adjusted fees for pharmacovigilance applications from 3 October 2022
Pharmacovigilance fees payable to the European Medicines Agency by applicants and marketing authorisation holders increase by 5.6% as of 3 October 2022, to reflect the inflation rate...
