International – ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals Step5
Historically, the regulatory requirements for the assessment of the carcinogenic potential of
pharmaceuticals in the three regions (E.U., Japan, U.S.) provided for the conduct of...
USA – FDA drafts guidance on pediatric clinical pharmacology studies
The US Food and Drug Administration (FDA) has laid out its thinking on the ethical and physiological issues sponsors should consider when planning to...
International – ICH M10 on bioanalytical method validation
This guideline is intended to provide recommendations for the validation of bioanalytical methods for chemical and biological drug quantification and their application in the...
USA – FDA revises guidance on delaying, denying, limiting or refusing an inspection
On Dec. 15, 2022, the FDA released for public comment Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1....
USA – FDA draft guidance addresses use of external controls to assess effectiveness of...
The FDA Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have issued draft guidance describing sponsors...
International – WHO warns on contaminated cough syrups linked to child deaths
This WHO Medical Product Alert refers to two substandard (contaminated) products, identified in Uzbekistan and reported to WHO on 22 December 2022. Substandard medical...
UK – Kidney Research UK concerned by NICE process
Kidney Research UK has responded to the National Institute for Health and Care Excellence (NICE) draft guidance on therapeutics for patients with COVID-19.
It follows...
International – ICH adopts S12 guideline for gene therapies
The International Council for Harmonisation (ICH) last week announced that its S12 guideline on nonclinical biodistribution (BD) considerations for gene therapy products has reached...
USA – Guidance details review process for pediatric research not approvable by an IRB
The US Food and Drug Administration (FDA) last week issued draft guidance offering insights to sponsors and institutional review boards (IRBs) on the process...
Europe – Fluoroquinolone antibiotics: reminder of measures to reduce the risk of long-lasting, disabling...
EMA’s safety committee, PRAC, is reminding healthcare professionals that the use of fluoroquinolone antibiotics, given by mouth, injection or inhalation, is restricted due to the...
