USA – Industry experts tout potential for master protocols in pediatric clinical trials

Using master protocols in pediatric clinical trials could speed the development of drugs for pediatric indications that already have development programs for adults, according...

USA – FDA issues draft guidance on developing migraine prevention drugs

The US Food and Drug Administration (FDA) on Thursday released a draft guidance to help sponsors develop drugs to prevent migraines that offers recommendations...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – UK’s MHRA approves first drug under international recognition procedure

The UK Medicines and Healthcare products Regulatory Agency (MHRA) recently approved Amgen’s bone cancer drug Xgeva (denosumab), the first drug submitted through the international...

USA – FDA seeks feedback on ICH E6(R3) GCP guideline

The US Food and Drug Administration (FDA) has started its public consultation for the International Council for Harmonisation (ICH) guideline on good clinical practice...

USA – FDA issues draft guidance on pulmonary tuberculosis drugs

The US Food and Drug Administration (FDA) has released new draft guidance on developing drugs for pulmonary tuberculosis. FDA’s latest draft guidance is intended to...

USA – Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry

This guidance provides recommendations to assist industry and other parties involved in the development of antibody-drug conjugates (ADCs) with a cytotoxic small-molecule drug or...

UK – NICE approves funding for Novartis gene therapy

NICE has published final draft guidance regarding the recommendation of routine NHS funding for onasemnogene abeparvovec. The treatment is a potentially curative one-off gene therapy...

Europe – New Quality Innovation Expert Group (QIG) supports medicine innovation

EMA has established a Quality Innovation Expert Group (QIG) to support innovative approaches for the development, manufacture, and quality control of medicines for the benefit of...

Europe – PRAC starts review of topiramate use in pregnancy and women of childbearing...

EMA’s safety committee (PRAC) has started a review of topiramate and the risk of neurodevelopmental disorders in children whose mothers were taking topiramate during...

USA – Biosimilar labeling guidance suggests cutting interchangeability details from labels

In new draft guidance on biosimilar labeling, the US Food and Drug Administration (FDA) recommends removing details about interchangeability from the labels of these...