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Regulatory Affairs

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: January 24, 2022, 8:07 pm
“Now more than ever, we need to understand the implications sex and gender present for the performance of medical devices in all individuals. The CDRH Health of Women program is a comprehensive, collaborative, landmark program built on the premise that both sex and gender have a considerable impact on women’s overall health, not just their reproductive or sexual health,” Terri Cornelison, MD, PhD, chief medical office and director of the Health of Women Program at CDRH, said in a statement.
Posted: January 21, 2022, 7:47 pm
Updated 21 January to include new information on Olumiant, Lagevrio, Regkirona, Paxlovid, Xevudy, Veklury, and ensovibep.
Posted: January 21, 2022, 7:08 pm
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week, we look at some newly published data from FDA on its user fee program performance, REMS programs and generic drug approvals.
Posted: January 21, 2022, 1:00 pm
The European Parliament approved legislation to increase the powers of the European Medicines Agency (EMA) in monitoring and responding to drug and device shortages.
Posted: January 20, 2022, 10:51 pm


Peptilogics, a biotech company that designs peptide therapeutics, today announced that it has promoted Nicholas Nystrom, Ph.D., formerly SVP and Head of Computation and Data, to Chief Technology Officer.
Posted: January 24, 2022, 12:00 am
Asher Biotherapeutics today announced the expansion of its executive leadership team with the appointments of Don O’Sullivan, Ph.D., M.B.A., as Chief Business Officer, James Cross, Ph.D., as Vice President, Regulatory Affairs and Florence Zhu, CPA, as Vice President, Finance.
Posted: January 24, 2022, 12:00 am
Goldfinch Bio today announced the appointment of Edwin (Ed) Tucker, M.D., as Chief Medical Officer (CMO), effective immediately.
Posted: January 24, 2022, 12:00 am
The San Diego-based immunology company is locating and developing molecules where the mechanism of action has either been proven or makes sense.
Posted: January 24, 2022, 12:00 am
Oncopeptides gave no further details about its decision. However, the company has initiated a dialogue with the FDA to review the new data.
Posted: January 24, 2022, 12:00 am


Sanofi is urging the Toronto City Council to restrict development of a residential property over concerns that the building heights could make it easier to spy on an expanding vaccine…
Author: Ed Silverman
Posted: January 24, 2022, 8:57 pm
An advocacy group is pressing Pfizer to swiftly expand access to it pill to treat Covid-19 in low-income countries.
Author: Ed Silverman
Posted: January 24, 2022, 5:42 pm
So here is the big question for Hal Barron as he departs GlaxoSmithKline: Did he accomplish his mission to turnaround its labs?
Author: Ed Silverman
Posted: January 24, 2022, 2:25 pm
What's ailing biotech stocks lately? An analyst offers some explanations.
Author: Adam Feuerstein and Meg Tirrell and Damian Garde
Posted: January 24, 2022, 10:00 am
As Americans come to value rapid home testing for Covid-19, I believe this will usher in a new era of health care in which people feel comfortable testing for a…
Author: Yonatan Adiri
Posted: January 24, 2022, 9:45 am

Human Resources

Most social gaffes fall closer to the less egregious end of the spectrum, but that doesn't mean they can be ignored, writes one workplace expert.

Author: Heather Vough
Posted: January 24, 2022, 9:18 pm

Lioness brings a new offering to the recruiting landscape. Part investigation. Part first-person narrative. Fully bombshell.

Author: Carla Bell
Posted: January 24, 2022, 5:28 pm

The U.S. Supreme Court recently blocked a nationwide workforce vaccine mandate, but such efforts remain an important defense for employers, the National Association of Manufacturers said.

Author: Kate Tornone
Posted: January 21, 2022, 4:07 pm

Retention may prove equally as challenging as recruiting.

Author: Ryan Golden
Posted: January 21, 2022, 3:53 pm

To get talent from application to onboarding, HR teams will need to bring their A-game in these areas.

Author: Caroline Colvin
Posted: January 21, 2022, 1:33 pm