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...
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...
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The US Food and Drug Administration (FDA) has published draft guidance for sponsors developing drugs and biologics for weight reduction for patients who are...
USA – AI in drug development: FDA draft guidance addresses product lifecycle, risk
The US Food and Drug Administration (FDA) has released a new draft guidance on the use of artificial intelligence (AI) that produces data or...
USA – Batch uniformity: FDA details testing approaches for continuous manufacturing, 3D printing
The US Food and Drug Administration (FDA) has issued draft guidance to assist manufacturers in complying with its good manufacturing practice (GMP) regulations under...
Canada – Drug and medical device databases
This list of Health Canada's drug and medical device databases briefly describes the information available in each database. It does not provide an in...
USA – Researchers suggest FDA needs authority to require pediatric studies for orphan drugs
The US Food and Drug Administration (FDA) may need greater authority to require pediatric clinical studies for drugs, including orphan drugs, according to a...
USA – FDA finalizes BIMO electronic submission guidance
The US Food and Drug Administration (FDA) has finalized guidance for sponsors on electronically submitting data on drugs and biologics that the agency will...
USA – Accelerated approval: FDA revises guidance to reflect revised withdrawal procedures
The US Food and Drug Administration (FDA) on Thursday issued draft guidance that would replace the accelerated approval portion of its broader guidance covering...
