USA – FDA issues QMSR final rule with 2-year transition period
The US Food and Drug Administration (FDA) has published its long-awaited Quality Management System Regulation (QMSR) final rule that harmonizes its requirements with a...
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 releases discussion paper on distributed and point-of-care manufacturing
The US Food and Drug Administration (FDA) has released a discussion paper on emerging and advanced manufacturing technologies concerning the distributed manufacturing (DM) and...
USA – Novel Drug Approvals for 2023
Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When it comes the development of...
USA – FDA adds microbiological assessments to ophthalmic drug quality guidance
The US Food and Drug Administration (FDA) recently issued a revised draft guidance for topical ophthalmic drugs recommending that manufacturers follow certain microbial testing...
USA – FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs
Today, the U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for potential...
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 – FDA approves first treatment for Rett Syndrome
FDA has approved Daybue (trofinetide) oral solution as the first treatment for Rett syndrome, a rare, genetic neurological disorder. Daybue is approved for the...
USA – FDA describes agency’s initiatives to accommodate growth in cell and gene therapy...
A US Food and Drug Administration (FDA) official discussed the agency’s recent efforts to spur the development of cell and gene therapies during a...
USA – Legislation could catalyze EU pharma industry innovation
The EU pharmaceutical industry has warned that the bloc is lagging behind when it comes to innovation and losing its position in the global...
