USA – FDA finalizes guidance on DSCSA waivers, exceptions and exemptions
The US Food and Drug Administration (FDA) recently published a final guidance on its process for granting – or denying – waiver, exceptions and...
USA – Drugmakers ask FDA to reconsider concomitant treatment in migraine drug guidance
Four drugmakers have asked the US Food and Drug Administration (FDA) to amend some of the requirements in its draft guidance on developing migraine prevention...
Canada – Notice: Release of (Step 4) ICH S12 Guideline – Nonclinical Biodistribution Considerations...
This topic was endorsed by the ICH Assembly in June 2019.
The ICH S12 Guideline reached Step 4 of the ICH process on 14 March 2023.
The ICH...
USA – FDA approves second over-the-counter naloxone nasal spray for opioid overdose
The FDA’s decision means that RiVive stands as the second non-prescription, OTC naloxone nasal spray product that the agency has approved.
FDA commissioner, Robert Califf,...
USA – Pharmaceutical distributors seek two-year delay in DSCSA tracking rules
Pharmaceutical distributors are calling for the US Food and Drug Administration (FDA) to grant a two-year delay enforcing the pharmaceutical tracking provisions of the Drug...
USA – Labeling, DTC advertising and compounding rules make FDA’s semiannual regulatory agenda
The US Department of Health and Human Services (HHS) has published its semiannual regulatory agenda that includes rules the Food and Drug Administration (FDA)...
USA – FDA finalizes guidance on drug quality consensus standards recognition program
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Wednesday published a final guidance on its process for...
USA – FDA issues draft guidance on reporting manufacturing changes for gene therapies
The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Friday issued a guidance to assist sponsors of cell...
USA – FDA Approves New Drug to Prevent RSV in Babies and Toddlers
Today, the U.S. Food and Drug Administration approved Beyfortus (nirsevimab-alip) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates...
USA – FDA revises IEM drug draft guidance to clarify food standards, use of...
The US Food and Drug Administration (FDA) has issued a revised draft guidance on developing drugs to treat inborn errors of metabolism (IEM) to...
