Regulatory affairs

Latest COVID-19 news from the FDA

17-Sep-2020 By Jenni Spinner

The US agency continues to issue advice for life-sciences professionals engaged in work related to the virus, and keep an eye out for fraudulent products.

Women in pharma face unique obstacles: Shorla Pharma

16-Sep-2020 By Jenni Spinner

A cofounder of the Irish pharmaceutical firm will join others in sharing her perspective as a female pharmaceutical leader at this year’s CPhI event.

CPhI shifts from real-world to digital realm

16-Sep-2020 By Jenni Spinner

In the face of the COVID-19 pandemic, CPhI Festival of Pharma organizers have shifted the event online but kept the industry content.

Breaking FDA COVID-19 news

26-Aug-2020 By Jenni Spinner

The agency continues to take actions and issue advice related to COVID-19 treatments, tests, consumer products and other pressing industry concerns.

Eversana partners on migraine treatment launch

25-Aug-2020 By Jenni Spinner

The company is joining with Zosano Pharma to aid the commercialization and distribution of Qtrypta, a transdermal migraine treatment candidate.

Current FDA COVID-19 news

13-Aug-2020 By Jenni Spinner

The US federal agency continues to keep busy offering resources, issuing EUAs and taking action related to the COVID-19 pandemic.

Potential HIV cure Phase I trial gets FDA green light

11-Aug-2020 By Jenni Spinner

American Gene Technologies has received the agency’s approval to launch the first human trial for its lead HIV program, starting in Baltimore and DC.

PRA: get ready for the RACE Act

10-Aug-2020 By Jenni Spinner

Experts from the CRO offers insight on preparing for the changes to the pediatric oncology research requirements, which take effect next week.

This week's FDA COVID-19 news

06-Aug-2020 By Jenni Spinner

The agency continues to provide resources for the life-sciences industry, approve tests, and take action against companies offering false treatments

COVID-19 highlights US dependence on foreign pharma: CEO

05-Aug-2020 By Jenni Spinner

An executive from Pharmaceutical Associates Inc. believes bringing drug manufacturing back to the country will help avoid shortages and other disasters.

Senate bill proposes study of the US pharma supply chain

05-Aug-2020 By Jenni Spinner

The bipartisan bill calls for an assessment of the country’s pharma supply chain, including potential vulnerabilities and impact of foreign manufacturing.

Most recent FDA COVID-19 updates

30-Jul-2020 By Jenni Spinner

The US agency continues to put out informational resources, issue EUAs for tests and treatments, and monitor industry activity related to the virus.

Kodak Pharmaceuticals lands $765m US loan

30-Jul-2020 By Jenni Spinner

The imaging company’s newly launched division, created to produce drug ingredients, received the loan from the US International Development Finance Corp.