US Food and Drug Administration (FDA)

RPS calls for crackdown on e-cigarette liquids resembling children’s foods

The US Food and Drug Administration has succeeded in stopping US online retailers providing nicotine-containing e-liquids with labelling or advertising that resemble child-friendly food products but UK firms are continuing to sell them.…

FDA permits marketing of first mobile app for contraception

The first mobile medical application to be used as a method of contraception has been granted marketing approval by the US Food and Drug Administration.…

FDA grants first approval of a cannabis-derived medicine

A cannabis-derived medicine has been approved for the first time by the US Food and Drug Administration.…

First implantable glucose monitor approved by FDA

The first continuous glucose monitoring system with a fully implantable sensor has been approved by the US Food and Drug Administration.…

New FDA guidance on development of sustained-release buprenorphine for treatment of opioid dependence

The US Food and Drug Administration (FDA) has published the first of two new draft guidance documents aimed at helping the pharmaceutical industry develop drugs for use in medication-assisted treatment (MAT) for opioid dependence.…

FDA issues guidance on developing new genetic tests for diagnosis and treatment of disease

The US Food and Drug Administration (FDA) has issued two sets of guidance to drive the design, development and validation of new genetic and genomic-based tests using next generation sequencing (NGS). NGS works by looking at a person’s DNA to detect genomic variations that may determine whether a…

Sales of unapproved antibiotic formulations are rising in India, study finds

Sales of antibiotic fixed-dose combinations, including unapproved formulations, are rising in India, according to a study published in the British Journal of Clinical Pharmacology.…

FDA calls for label change on anti-diarrhoea drug to stem misuse by opioid users

US Food and Drug Administration calls for changes to how loperamide is packaged so that it can be sold in smaller quantities, for short-term use only.…

New rare disease medicines boost drug approvals

Growth in the development of rare disease medicines has helped boost the number of new drugs approved in the both the US and the EU, according to Reuters.…

FDA aims to speed up approvals of generic drugs

The US Food and Drug Administration has published guidance aimed at speeding up approvals of generic drugs.…