Regulations

This week’s FDA COVID-19 updates

23-Jul-2020 By Jenni Spinner

The US agency continues releasing resources, offering advice and taking actions related to the pandemic, and how life-sciences professionals respond.

Weekly FDA COVID-19 updates and actions

08-Jul-2020 By Jenni Spinner

The agency continues to offer advice to pharma industry professionals during the global public health crisis, and offer advice on developing solutions.

FDA approves ViiV Healthcare’s HIV treatment

07-Jul-2020 By Jenni Spinner

The agency has given the thumbs up for Rukobia, a treatment designed for HIV patients facing poor results with current antiretroviral therapies.

This week’s FDA COVID-19 updates

25-Jun-2020 By Jenni Spinner

The US agency continues to issue advice, offer guidance and take action related to the virus behind the global pandemic.

FDA advises API makers on COVID-19 safe practices

24-Jun-2020 By Jenni Spinner

The agency's latest guidance offers advice on keeping manufacturing of active pharmaceutical ingredients safe during the COVID-19 pandemic.

Gilead gets green light for inhaled remdesivir study

23-Jun-2020 By Jenni Spinner

After receiving FDA approval, the pharmaceutical company has announced plans to launch a Phase I trial for an inhaled version of the COVID-19 treatment.

FDA COVID-19 updates for the week

18-Jun-2020 By Jenni Spinner

The federal agency continues to aid drug developers, trial teams and the public with advice and actions related to the virus behind the global pandemic.

Newest FDA actions and alerts on COVID-19

04-Jun-2020 By Jenni Spinner

The federal agency continues to monitor as the virus impacts the pharma and clinical trials industries, offering advice and taking action where necessary.

Latest FDA COVID-19 updates

27-May-2020 By Jenni Spinner

The federal agency continues to offer advice and take actions related to COVID-19, impacting drug development, clinical trials and other activities.

This week’s FDA COVID-19 updates

21-May-2020 By Jenni Spinner

The agency continues to offer advice and take actions impacting the pharmaceutical and life-science industries during the pandemic.

Nanoform granted GMP certification

14-May-2020 By Jenni Spinner

The Finnish nanoparticle technology specialist’s facility has been given the stamp of approval by the Finnish Medicines Agency.

This week's FDA COVID-19 actions and advice

13-May-2020 By Jenni Spinner

The federal agency continues to offer advice for healthcare and pharma industry professionals, and to take action against companies acting out of bounds.

Weekly FDA COVID-19 update

07-May-2020 By Jenni Spinner

The agency continues to remain busy overseeing and approving potential treatments and tests for the virus behind the global pandemic.

EPS taps CluePoints for trial management solution

27-Apr-2020 By Jenni Spinner

The Japanese pharma development firm will harness risk-based quality management solutions to help sponsors improve trial quality and safety.

FDA COVID-19 roundup: actions and advisories

15-Apr-2020 By Jenni Spinner

The federal agency has issued several guidances, provided updates and taken actions related to the global pandemic over the past seven days.