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Regulatory Affairs

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) recently released five warning letters sent to medical device manufacturers around the globe due to various violations.
Posted: April 1, 2020, 7:45 pm
The International Council for Harmonisation (ICH) on Wednesday announced that the Medical Dictionary for Regulatory Activities (MedDRA) is being updated with new supplemental terms and corresponding codes related to coronavirus disease (COVID-19).
Posted: April 1, 2020, 7:39 pm
The US Food and Drug Administration (FDA) last week updated its guidance from earlier this month on conducting clinical trials during the coronavirus disease (COVID-19) pandemic.
Posted: April 1, 2020, 7:37 pm
Two drugs primarily used to treat malaria, chloroquine and hydroxychloroquine, should not be used to treat coronavirus disease (COVID-19) outside of clinical trials or emergency use programs, the European Medicines Agency (EMA) said Wednesday.
Posted: April 1, 2020, 7:27 pm
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: April 1, 2020, 5:06 pm


Neurimmune AG and Ethris GmbH announced an exclusive partnership to develop mRNA-encoded, neutralizing anti-SARS-CoV-2 antibodies administered by inhalation for the treatment of COVID-19.
Posted: April 1, 2020, 12:00 am
Amgen K.K. Will Focus on Bringing Amgen's Full Global Pipeline to Japanese Patients.
Posted: April 1, 2020, 12:00 am
Alligator Bioscience, announced a temporary halt in the recruitment of new patients to the company's ongoing Phase I clinical trials with the drug candidates ATOR-1015 and ATOR-1017.
Posted: April 1, 2020, 12:00 am
Ascletis Pharma Inc. announces that its partner Sagimet Biosciences, will present clinical and preclinical data on non-alcoholic steatohepatitis drug candidate TVB-2640 at the upcoming European Association for the Study of the Liver International Liver Congress™ 2020 in London, which has been postponed to 25-28 August..
Posted: April 1, 2020, 12:00 am
Company highlights significant R&D investments, progress in cell therapy, especially in CAR-T Trials Targeting Gastric Cancer and Other Pipelines
Posted: April 1, 2020, 12:00 am


It is shameful in 2020 to see some universities sign on to a coalition like Bayh-Dole 40 that actively aims to undermine a safeguard that exists to serve the public…
Author: Varoon Mathur
Posted: April 2, 2020, 8:50 am
Medical school didn't teach me how to decide which of my patients should live and which should die if it becomes necessary to ration medical equipment or treatment. But I've…
Author: Kelly Michelson
Posted: April 2, 2020, 8:45 am
Redpin and CODA are taking existing compounds, tailoring receptors to match them, and delivering the genetic code for the bespoke receptors via gene therapy — a technique known as chemogenetics.
Author: Kate Sheridan
Posted: April 2, 2020, 8:40 am
Bracing for a surge of #Covid19 patients, hospitals and governments are grappling an unimaginable question: If ventilators and intensive care unit beds must be rationed, who should get them?
Author: Megan Thielking
Posted: April 2, 2020, 8:35 am
Traditional contact tracing procedures in the U.S. are not fast enough for the new #coronavirus. But existing digital tools could make them instantaneous.
Author: Sharon Begley
Posted: April 2, 2020, 8:30 am

Human Resources

Misclassification of employees under the FLSA is a common issue and can lead to costly litigation.

Author: Lisa Burden
Posted: April 2, 2020, 12:00 pm

The regulation is effective through the end of 2020.

Author: Ryan Golden and Kate Tornone
Posted: April 1, 2020, 9:02 pm

The clarifications came in the form of three opinion letters regarding the new regular rate regulations.

Author: Jennifer Carsen
Posted: April 1, 2020, 3:31 pm

The Willis Towers Watson report noted that relatively few employers have cut salaries, though wage freezes and delayed raises are on the table.

Author: Sheryl Estrada
Posted: April 1, 2020, 2:23 pm

Millions of jobs are at risk of layoffs due to COVID-19, and that figure grows as states and localities announce stricter public-health measures.

Author: Ryan Golden
Posted: April 1, 2020, 2:21 pm