USA – FDA draft guidance outlines appropriate use of tissue biopsies in clinical trials
When are tissue biopsies really needed in clinical trials of medical products? Draft guidance from the US Food and Drug Administration (FDA) offers recommendations...
International – WHO guideline aims to facilitate the development of “more durable” pediatric medicines
The World Health Organization (WHO) has released a draft guideline to encourage the development of better-formulated and higher-quality pediatric medicines. The guideline targets member...
USA – FDA proposes to modernize guidance on sex, gender in clinical trials
The US Food and Drug Administration (FDA) is proposing to update two guidance documents that clarify terminology around sex and gender of clinical trial...
International – ICH adopts E6(R3) guideline on good clinical practices
The International Council for Harmonisation (ICH) announced on Tuesday the adoption of its E6(R3) guideline, which aims to harmonize the framework for conducting clinical...
USA – CDER approved 50 novel drugs in 2024, record number of biosimilars
Innovation Across Medical Conditions
In 2024, we approved 50 new drugs never before approved or marketed in the U.S.,
known as “novel” drugs. We also made...
UK – NICE recommends olaparib for BRCA-mutated breast cancer treatment
The National Institute for Health and Care Excellence (NICE) has given a positive recommendation for Lynparza (olaparib) for NHS use in England and Wales.
This...
UK – AstraZeneca’s Lynparza recommended by NICE to treat advanced breast cancer
The health technology assessment agency has recommended that the drug be used on the NHS in England and Wales to treat adults with HER2-negative,...
USA – FDA finalizes advanced manufacturing technology designation guidance
The US Food and Drug Administration (FDA) has finalized a guidance to assist sponsors interested in participating in the Advanced Manufacturing Technology (AMT) designation...
USA – FDA proposes update to 18-year guidance on developing weight loss drugs
The US Food and Drug Administration (FDA) has published draft guidance for sponsors developing drugs and biologics for weight reduction for patients who are...
USA – AI in drug development: FDA draft guidance addresses product lifecycle, risk
The US Food and Drug Administration (FDA) has released a new draft guidance on the use of artificial intelligence (AI) that produces data or...
