USA – Guidance details review process for pediatric research not approvable by an IRB
The US Food and Drug Administration (FDA) last week issued draft guidance offering insights to sponsors and institutional review boards (IRBs) on the process...
USA – FDA to require mail-back envelopes for unused opioids
Drugmakers will soon have to provide patients with postage-paid envelopes to send back unused opioids for safe disposal under a new requirement announced by...
Europe – EMA recommends approval of Bimervax as a COVID-19 booster vaccine
EMA’s human medicines committee (CHMP) has recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a booster in people aged 16 years...
UK – AstraZeneca and Amgen’s Tezspire recommended by NICE for severe asthma
The final draft guidance from the National Institute for Health and Care Excellence (NICE) specifically applies to patients who are inadequately controlled with high...
USA – FDA Approves First Over-the-Counter Naloxone Nasal Spray
Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first...
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 – DARWIN EU® has completed its first studies and is calling for new...
DARWIN EU®, the Data Analysis and Real-World Interrogation Network, has accomplished its first year of establishment. Following the set-up of the DARWIN EU® Coordination...
Europe – ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from...
This document considers testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin. It outlines...
USA – FDA encourages RCTs in accelerated approval guidance for oncology
The US Food and Drug Administration (FDA) issued draft guidance on the design of oncology trials for accelerated approval, calling randomized controlled trials (RCTs)...
UK – NICE sees ‘promise’ in four UTI tests that could help in fight...
AMR develops when bacteria, viruses, fungi and parasites change and adapt to antibiotics over time, making them more resistant to drug treatments. As a...
