Regulations

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.

CluePoints bundles free COVID-19 risk management tools for trials

14-Apr-2020 By Jenni Spinner

The no-cost package includes solutions for addressing risk planning and mitigation in clinical trial operations.

Elligo partners with California on COVID-19 fight

13-Apr-2020 By Jenni Spinner

The company is working with the governor’s office and state, federal and local health authorities to expand COVID-19 screening and testing efforts.

Greenphire expands ConneX patient service solution

13-Apr-2020 By Jenni Spinner

The company’s ConneX Patient Direct service enables transport of trial medications, equipment and healthcare professionals directly to participants.

FDA COVID-19 response roundup

08-Apr-2020 By Jenni Spinner

The federal agency continues to take action and make announcements centered on nationwide efforts to combat the virus causing the global pandemic.

FDA updates and actions on COVID-19

01-Apr-2020 By Jenni Spinner

The federal agency has announced a slew of legislation, advisory statements and other items impacting the US in the face of the pandemic.

Gilead rescinds request for remdesivir orphan status

30-Mar-2020 By Jenni Spinner

The pharmaceutical company has withdrawn its orphan designation request for its antiviral for the treatment of COVID-19.

FDA grants chloroquine emergency authorization as coronavirus treatment

30-Mar-2020 By Vassia Barba

The US FDA has issued the first emergency use authorization to chloroquine phosphate and hydroxychloroquine sulfate as treatments against coronavirus.

Warning letter cites shredded documents and faulty cameras in facility

26-Mar-2020 By Vassia Barba

Windlas issued a warning letter by the US FDA after the regulator finds the manufacturer’s response inadequate to justify wrongdoings at its India facility.