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...
UK – AstraZeneca/Merck’s Lynparza recommended by NICE for advanced prostate cancer
The PARP inhibitor has been specifically recommended for NHS use alongside anti-androgen therapy Zytiga (abiraterone) and prednisone or prednisolone in adults with untreated hormone-relapsed...
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)...
Brazil – ANVISA approves skinny labeling in Brazil
On December 6, the Board of Directors (DICOL) of the Brazilian Food & Drug Agency (ANVISA) passed new regulations accepting an exemption to allow...
Europe – EU agencies adopt workplan on AI in medicines regulation
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have adopted a workplan to facilitate the “responsible and beneficial” use of...
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...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Seven new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2023 meeting.
The committee recommended granting a conditional...
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The US Food and Drug Administration (FDA) this week issued draft guidance detailing its new advanced manufacturing technologies (AMT) designation program, offering insights on...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...
Europe – First version of the Union list of critical medicines agreed to help...
The list is an important tool to support the EU’s efforts in ensuring supply security and preventing shortages of critical medicines. Inclusion in the...
