USA – FDA issues draft guidance of clinical pharmacology, labeling considerations for peptide drug...
The US Food and Drug Administration (FDA) has released a draft guidance outlining the agency’s clinical pharmacology and labeling considerations for peptide drug products.
When...
Europe – Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
EMA’s human medicines committee (CHMP) has recommended authorising an adapted Spikevax vaccine targeting the Omicron XBB.1.5 subvariant.
The vaccine — known as Spikevax XBB.1.5 — is...
USA – FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against...
Today, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently...
UK – Eli Lilly’s Mounjaro receives NICE recommendation to treat type 2 diabetes
According to NICE’s draft guidance, around 180,000 people living with difficult-to-manage type 2 diabetes could benefit from the new treatment option.
The recommendation follows additional...
UK – NICE issues two recommendations for UCB’s inflammatory disease drug
Bimzelx, which is already authorised in the UK to treat certain patients with plaque psoriasis, is now the first treatment available for PsA and...
France – Vaccination contre le Covid-19 et maternité
La vaccination est un acte médical. Elle repose sur deux piliers :
Le respect des dispositions générales du code de la santé publique concernant l’information...
New Zealand – Guidelines on the Regulation of Therapeutic Products in New Zealand
Medsafe requires evidence of compliance with Good Manufacturing Practice (GMP) for sites
used to manufacture and pack medicines. This evidence is required for medicines in...
USA – FDA finalizes guidance on use of human factors studies in combination product...
The US Food and Drug Administration (FDA) finalized its guidance for industry on the use of human factors engineering (HFE) studies to support the...
USA – FDA draft guidance focuses on postapproval trial diversity data
Sponsors can employ several postmarketing strategies to beef up safety and efficacy data on populations that were under-represented in initial clinical trials of drugs...
USA – FDA finalizes guidance on standards for tracing products through supply chain
The US Food and Drug Administration (FDA) will allow trading partners to track drug products through the pharmaceutical supply chain using portals and email...
