Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2020

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...

Europe – EMA seeks feedback on quality, therapeutic equivalence of inhaled drugs

The European Medicines Agency (EMA) has released two draft guidelines for consultation on inhaled medicines. One covers the pharmaceutical quality of inhalation and nasal...

Europe – New recommendations to strengthen supply chains of critical medicines

These recommendations have been developed by EMA’s Medicines Shortages Steering Group (MSSG) and will facilitate the availability and supply of critical human medicines for which vulnerabilities...

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...
WHO drafts guidance for pharma supply chain tracking

International – WHO issues guidance on nitrosamine controls in drug manufacturing

The World Health Organization (WHO) released draft guidance for comment this month on good manufacturing practices (GMP) for the prevention and control of contamination...

International – ICH M13A BE testing guideline expected to be adopted this summer

The International Council for Harmonisation (ICH) is expected to adopt its M13A guideline on bioequivalence (BE) testing of immediate-release (IR) solid oral dosage form...

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...

Europe – Parliament adopts its position on EU pharmaceutical reform

The legislative package, covering medicinal products for human use, consists of a new directive (adopted with 495 votes in favour, 57 against and 45...

Europe – Reflection papers on regulatory requirements for the development of medicinal products for...

The drafting of a reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) is intended in order to...

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: