USA – FDA finalizes guidance to limit use of benzene in drug products
The US Food and Drug Administration (FDA) recently finalized a guidance to expedite the reformulation of drug products that use inactive ingredients manufactured with...
Canada – Notice – Implementation of ICH E19: A selective approach to safety data...
Health Canada, as an official member to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), is committed to...
USA – FDA proposes master control trial guidance that goes beyond COVID-19
The US Food and Drug Administration (FDA) this week published a draft guidance on the use of master protocols in clinical trials of drugs...
USA – Stakeholders concerned with FDA’s definition of labeling in PDURS guidance
Stakeholders want the US Food and Drug Administration (FDA) to narrow its scope of what it considers labeling in a draft guidance for prescription...
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...
