USA – FDA finalizes guidances on RWD in regulatory submissions, assessing registries
The US Food and Drug Administration (FDA) on Thursday finalized two guidances that detail how sponsors can leverage and submit real-world data (RWD) in...
USA – FDA proposes updated medtech RWE guidance
The US Food and Drug Administration (FDA) has updated it’s guidance on how real-world data (RWD) can be used to provide real-world evidence (RWE)...
USA – FDA establishes advisory committee for genetic metabolic disease treatments
The Genetic Metabolic Diseases Advisory Committee will advise the FDA on products used for the diagnosis, prevention and treatment of genetic metabolic diseases under...
USA – FDA guidance details new advanced manufacturing technology designation program
The US Food and Drug Administration (FDA) this week issued draft guidance detailing its new advanced manufacturing technologies (AMT) designation program, offering insights on...
USA – Experts discuss red flags that can trigger legal action against drug and...
Legal observers discussed some of the red flags that can trigger legal actions against healthcare product manufacturers, as well as some of the lessons...
USA – Fall unified agenda includes new rule on removing outdated regulations, returning QMSR...
The Department of Health and Human Services (HHS) recently published the fall 2023 unified agenda for the US Food and Drug Administration (FDA) that...
USA – FDA finalizes guidance on DSCSA verification systems
The US Food and Drug Administration (FDA) on 7 December issued a final guidance describing procedures to help trading partners establish systems to identify,...
USA – Combination products: FDA experts address UDI, harmonization, OPQ reorganization
Officials from the US Food and Drug Administration (FDA) fielded wide-ranging questions on the development and marketing of combination products — from UDI requirements...
USA – FDA investigates risk of secondary malignancies with CAR T-cell therapy
The US Food and Drug Administration (FDA) is investigating reports of a “serious risk” of T-cell malignancies linked to treatment with chimeric antigen receptor...
USA – Combination products: Non-harmonized regulations are hurting manufacturers
Divergent global regulatory frameworks are making it tough for manufacturers to move ahead with innovative combination drug/device products, according to a panel of experts...
