Regulatory affairs

This week’s FDA COVID-19 news

02-Jul-2020 By Jenni Spinner

The agency continues to offer advice for drug developers and other stakeholders, and to take action against companies that step out of line.

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.

Cascade Chemistry to produce API for COVID-19 trial

24-Jun-2020 By Jenni Spinner

Tapped by Renibus Therapeutics, the CDMO will produce the API for clinical trials of investigational drug RBT-9 for an upcoming COVID-19 study.

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.

Current FDA COVID-19 updates and actions

10-Jun-2020 By Jenni Spinner

The agency continues to offer advice related to drug development and clinical research during the pandemic, and take action against those falling out of line.

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.

Rho: evolution of drug development reflects focus on quality

29-May-2020 By Jenni Spinner

A representative of the research and development firm offers perspective on how the industry has shifted in recent years, thanks to a number of forces.

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.

Avalere: FDA can impact COVID-era drug development

18-May-2020 By Jenni Spinner

A representative of the life-sciences consulting firm outlines how the federal agency has reacted to the COVID-19 pandemic, and how it might advise the industry going forward.

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.

This week’s FDA COVID-19 news

30-Apr-2020 By Jenni Spinner

The agency continues to offer guidance about COVID-19 treatments and tests—and issue warnings to companies that fall out of line.

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 update on COVID-19 actions and advisements

23-Apr-2020 By Jenni Spinner

Over the past week, the agency has issued guidances, taken action to accelerate treatments and put a stop to fraudulent treatments for the pandemic-causing virus.

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.