UK – Emergency kits for people with adrenal insufficiency recommended to avoid hospital admission
The kits would be used help those with primary or secondary adrenal insufficiency to treat and avoid an adrenal crisis and the need to...
USA – FDA guidance addresses developing treatments for pediatric IBD
The US Food and Drug Administration (FDA) on Wednesday issued a draft guidance to spur the development of new treatments for pediatric ulcerative colitis...
Switzerland – Swiss Medtech soutient les négociations concernant un paquet d’accords bilatéraux lll
Pour l'industrie suisse des technologies médicales, la sécurité juridique est primordiale dans les relations avec l’UE. Swiss Medtech soutient donc le Conseil fédéral dans...
Europe – Streamlining development and assessment of biosimilar medicines
EMA is exploring improvements to the development and evaluation of biosimilar medicines, while upholding strict European Union (EU) safety standards. With over two decades...
USA – FDA proposes removing oral phenylephrine from use in nasal decongestants
The US Food and Drug Administration (FDA) announced on Thursday plans to remove oral phenylephrine from the over-the-counter (OTC) monograph for nasal decongestants following...
UK – New restrictions on puberty blockers
The government has today introduced regulations to restrict the prescribing and supply of puberty-suppressing hormones, known as ‘puberty blockers’, to children and young people under 18 in...
USA – FDA updates guidance on remote regulatory assessments
The US Food and Drug Administration (FDA) has revised its draft guidance on remote regulatory assessments (RRAs), outlining how it plans to use both...
Europe – Global regulators confirm good safety profile of COVID-19 vaccines
EMA has just endorsed a joint statement on the safety of COVID-19 vaccines issued by the International Coalition of Medicines Regulatory Authorities (ICMRA).
Evidence from more than 13...
France – L’ANSM classe plusieurs vaccins sur la liste I des substances vénéneuses
L’ensemble des vaccins, à l’exception des vaccins grippaux, est désormais classé sur la liste I des substances vénéneuses, à la suite d’une décision de...
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Stakeholders want the US Food and Drug Administration (FDA) to narrow its scope of what it considers labeling in a draft guidance for prescription...
