USA – FDA exploring model master files to expedite generic drug development
The US Food and Drug Administration (FDA) is exploring the use of model master files (MMFs) to enable sponsors to use the same modeling...
USA – Emerging technologies and regulatory agency guidance for CGTs
Advances in cellular and gene therapies (CGTs) – referred to as advanced therapy medicinal products (ATMPs) in the EU – offer opportunities for treating...
USA – FDA drafts two guidances on safety testing for cell and gene therapy...
The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Tuesday issued two draft guidances related to cell and...
USA – FDA issues three guidances to expand cancer clinical trial eligibility
The US Food and Drug Administration’s (FDA) has issued a trio of draft guidance documents that aim to promote greater participation and diversity in...
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:
