USA – Drug, device makers scramble for tariff exemptions, warn of supply disruptions
Drug and device manufacturers are raising concerns about President Donald Trump’s tariffs on imports from China, Mexico, and Canada, warning that they could worsen...
USA – FDA approves new Alzheimer’s treatment regimen
The US Food and Drug Administration (FDA) has approved Eisai and Biogen’s Supplemental Biologics License Application for once every four weeks intravenous (IV) maintenance...
USA – CDER announces new guidance agenda for 2025
The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has released a new guidance agenda detailing the new and revised guidance...
USA – FDA draft guidance outlines appropriate use of tissue biopsies in clinical trials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 Draft guidance from the US Food and Drug Administration (FDA) offers recommendations...
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The US Food and Drug Administration (FDA) has published draft guidance for sponsors developing drugs and biologics for weight reduction for patients who are...
USA – AI in drug development: FDA draft guidance addresses product lifecycle, risk
The US Food and Drug Administration (FDA) has released a new draft guidance on the use of artificial intelligence (AI) that produces data or...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The US Food and Drug Administration (FDA) has issued draft guidance to assist manufacturers in complying with its good manufacturing practice (GMP) regulations under...
