Canada – Notice – Implementation of ICH E19: A selective approach to safety data...
Health Canada, as an official member to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), is committed to...
USA – FDA Approves First Gene Therapy for Treatment of Certain Patients with Duchenne...
Today, the U.S. Food and Drug Administration approved Elevidys, the first gene therapy for the treatment of pediatric patients 4 through 5 years of...
USA – FDA turns attention to data integrity lapses at testing sites in new...
The US Food and Drug Administration (FDA) has issued a draft guidance outlining how manufacturers can ensure the data integrity of bioavailability (BA) and...
USA – FDA finalizes guidance on cannabis clinical research
The US Food and Drug Administration has finalized a 2020 draft guidance outlining how sponsors and investigators can conduct clinical trials for certain drugs...
USA – Industry groups seek changes to nonprescription drug access proposal
Drugmakers, pharmacists and others are calling for flexibility in the US Food and Drug Administration’s (FDA) proposed rule on requirements for nonprescription drug products...
USA – Industry pushes FDA for tailored complex generics post-approval changes guidance
The US Food and Drug Administration (FDA) needs to develop guidance on post-approval changes for complex generics, and to update its guidance on post-approval...
USA – FDA issues final guidance on major statement in DTC ads
The US Food and Drug Administration (FDA) last week published a final guidance detailing five standards drug manufacturers should follow to ensure direct-to-consumer (DTC)...
USA – FDA guidance targets dose banding information in drug labels
The US Food and Drug Administration (FDA) has released draft guidance to assist sponsors with incorporating dose banding information in drug labeling for ready-to-use containers in...
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 – FDA encourages RCTs in accelerated approval guidance for oncology
The US Food and Drug Administration (FDA) issued draft guidance on the design of oncology trials for accelerated approval, calling randomized controlled trials (RCTs)...
