USA – FDA issues long-awaited LDT final rule
After years of jostling with industry, failed legislative efforts, and some false starts, the US Food and Drug Administration (FDA) has unveiled its plan...
USA – FDA updates guidance on promotional labeling and advertising of biosimilars
The US Food and Drug Administration (FDA) has published revised guidance on promotional labeling and advertising for prescription biosimilar drugs and their reference products.
The...
USA – CBER chief on remote work, CRISPR-Cas9, and rare disease gene therapy accelerated...
The use of CRISPR-Cas9 gene editing technology has potential to transform the field of gene therapy through its simple and cost-effective delivery mechanism, said...
USA – FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer
Efficacy was demonstrated in a global, randomized, open-label trial (ALINA, NCT03456076) in patients with ALK-positive NSCLC who had complete tumor resection. Eligible patients were...
USA – FDA launches new clinical trial center to improve innovation, communication
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has launched a new center for internal and external experts...
USA – Clinical Pharmacology Considerations for Antibody-Drug Conjugates – Final Guidance for Industry
FDA published the final guidance for industry, Clinical Pharmacology Considerations for Antibody-Drug Conjugates, and recently published accompaniments to the guidance document:
USA – Data Integrity for In Vivo Bioavailability and Bioequivalence Studies: Guidance for Industry
The purpose of this guidance is to provide recommendations to applicants and testing site
management on achieving and maintaining data integrity for the clinical and...
USA – Center for Drug Evaluation and Research – Office of Pharmaceutical Quality :...
FDA’s Office of Office of Pharmaceutical Quality (OPQ) published its 2023 Annual Report, which details the many ways OPQ assures the availability, safety, and...
USA – Study: Few FDA-approved targeted cancer drugs meet ESMO benefit benchmarks
Fewer than one-third of molecularly targeted cancer drugs recently approved by the US Food and Drug Administration (FDA) meet established European benchmarks for clinical...
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The US Food and Drug Administration (FDA) has issued a draft guidance outlining how manufacturers can ensure the data integrity of bioavailability (BA) and...
