France – FDA guidance calls for testing all alcohol-based products for methanol
The US Food and Drug Administration (FDA) issued final guidance to assist manufacturers and compounders in testing alcohol products (ethanol and isopropyl) for methanol....
USA – FDA offers guidance on development of antimicrobials for diabetic foot infections
The US Food and Drug Administration (FDA) released new draft guidance on developing antimicrobial drugs specifically intended to treat diabetic foot infection, a focused...
USA – FDA issues guidance on assessing quality of topical ophthalmic drugs
The US Food and Drug Administration (FDA) issued new draft guidance recommending a battery of studies that manufacturers should use to assess the quality...
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 October 2023 meeting.
The CHMP adopted a positive opinion for Agamree* (vamorolone),...
UK – Guidance : Full pack dispensing of valproate-containing medicines
This is guidance for dispensing of valproate-containing medicines in the manufacturer’s original full pack, following amendments to the Human Medicines Regulations (HMRs). These amendments...
International – Convergence: Confusion lingers over interchangeability and switching of biosimilars
While there are some areas of general alignment on standards for accepting biosimilar applications in the US, EU and Canada, some differences are impeding...
Latin America – Brazil, Mexico launch efforts to ease biosimilar regulation
In recent weeks, both Brazilian and Mexican regulatory authorities have made public their eagerness to spur domestic production – and faster regulation – of...
Europe – Convergence: EMA official urges transition of existing clinical trials to CTIS portal
Sponsors should plan to transition existing clinical trials into the new Clinical Trial Information System (CTIS) portal by 30 January 2025, Anabela Marcal, of...
USA – Convergence: FDA looking for ‘a new way forward’ on CBD regulation
The US Food and Drug Administration (FDA) is open to developing a new regulatory framework for cannabidiol (CBD), according to an agency official who...
USA – Convergence: Psychedelic drug development is ‘hot,’ but proceed with caution
Psychedelic drug development is receiving more attention lately as these treatments offer the potential for needed therapeutic alternatives for various mental health conditions, yet...
