USA – FDA officials impart lessons learned from quality management maturity pilots
The US Food and Drug Administration’s (FDA) should brief pilot participants ahead of the actual assessments and use a simplified rubric for scoring or...
Europe – European Commission grants AstraZeneca three new approvals
The Imfinzi/ Imjudo approvals authorise the combination to be used for the first line treatment of adult patients with advanced or unresectable hepatocellular carcinoma...
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USA – FDA revises ANDA facility correspondence draft guidance
The US Food and Drug Administration (FDA) on Friday revised its draft guidance on submitting pre-submission facility correspondence (PFC) for generic drug applicants seeking...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USA – FDA issues draft guidance on developing migraine prevention drugs
The US Food and Drug Administration (FDA) on Thursday released a draft guidance to help sponsors develop drugs to prevent migraines that offers recommendations...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UK – NICE publishes draft guidance recommending three COVID-19 treatments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...
