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Regulatory Affairs

The US Food and Drug Administration (FDA) has determined that Organogenesis, Inc. has failed to meet the postmarketing requirement of the Pediatric Research Equity Act (PREA) for its Biologics License Application (BLA) for Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen (GINTUIT).
Posted: August 18, 2017, 12:00 am
Clinical-stage biopharma Protalex, Inc. on Thursday said it has been awarded a $403,000 grant from the US Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) to support future clinical development activity of PRTX-100 as a treatment for immune thrombocytopenia (ITP).
Posted: August 18, 2017, 12:00 am
The US Food and Drug Administration (FDA) has laid out the process by which doctors can access an investigational drug for treatment use in an individual patient in an emergency situation, both during and after normal business hours in a new Manual of Policies and Procedures.
Posted: August 18, 2017, 12:00 am
The US Food and Drug Administration’s (FDA) recent push to reshape how it regulates digital health products with shifts to third-party certification and more postmarket reviews is called into question by three law professors in Health Affairs, who offer up three questions about the direction of the plan.
Posted: August 17, 2017, 12:00 am
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: August 17, 2017, 12:00 am

Biotechnology

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Posted: August 17, 2017, 12:00 am
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Posted: August 16, 2017, 12:00 am
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Posted: August 16, 2017, 12:00 am
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Posted: August 15, 2017, 12:00 am

Pharmaceuticals

President Trump signed a sweeping measure that will help ensure the Food and Drug Administration can continue to oversee drug and device approvals.
Author: Erin Mershon
Posted: August 19, 2017, 12:10 am
President Trump’s refusal to unequivocally denounce marchers who chanted racist and anti-Semitic slogans in Charlottesville is explained by his narcissism, psychologists say.
Author: Sharon Begley
Posted: August 18, 2017, 4:13 pm
Their methods involve noticing certain “tells” that indicate a customer is shopping for a firearm with suicide in mind.
Author: Shefali Luthra — Kaiser Health News
Posted: August 18, 2017, 2:21 pm
Quality scores for the vast majority of hospices were near the top — so good that some questioned whether consumers will find the data useful.
Author: Cheryl Clark — inewsource/MedPage Today
Posted: August 18, 2017, 1:54 pm
Two Democratic lawmakers, Reps. Elijah Cummings and Peter Welch, are demanding answers on the escalating prices of multiple sclerosis drugs.
Author: Damian Garde
Posted: August 18, 2017, 1:45 pm

Human Resources

Retail workers account for 10% of the 16 million people in the labor force, and now outnumber those in manufacturing and mining.

Posted: August 18, 2017, 1:43 pm

After Charlottesville, it's clear social media has blurred the line between personal and professional. Lawyer and blogger Jon Hyman spoke with HR Dive about its impact on people management.

Posted: August 18, 2017, 1:31 pm

While they are the new hot trend, open offices are not for everybody. Just ask some Apple workers.

Posted: August 18, 2017, 1:30 pm

Mental health stigma is declining, but affected workers are still mum on their diagnoses.  

Posted: August 18, 2017, 12:54 pm

In an age of talent shortages, recruiters are looking for hero employees who believe in the company brand.

Posted: August 17, 2017, 6:41 pm