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Regulatory Affairs

The US Food and Drug Administration (FDA) issued final guidance intended to help industry determine applicable requirements for a change to a medical device manufacturing site.
Posted: December 14, 2018, 9:04 pm
Retiring Sen. Orrin Hatch (R-UT) and two Republican colleagues in the House and Senate proposed a bill earlier this week to prevent generic drug applicants from taking advantage of the inter partes review (IPR) created under the America Invents Act.
Posted: December 14, 2018, 7:55 pm
A joint US Food and Drug Administration (FDA) advisory committee is meeting next Monday and Tuesday to discuss ways to increase the availability of the opioid overdose antidote known as naloxone as the opioid crisis continues.
Posted: December 14, 2018, 7:39 pm
With the volume of US Food and Drug Administration (FDA) regulated products imported into the US surging each year, the agency has been working on a more strategic approach to its regulation on imports by establishing several new systems for industry and agency staff.
Posted: December 14, 2018, 6:44 pm
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: December 14, 2018, 5:32 pm


MYOS RENS Technology Inc. issued the following letter to shareholders from MYOS CEO Joseph Mannello
Posted: December 14, 2018, 12:00 am
Shares of New Jersey-based Advaxis have plunged more than 28 percent in premarket trading after the company quietly disclosed that Amgen terminated its collaboration on an immuno-oncology program. The deal between the two companies was first inked in 2016 and had a value of up to $540 million.
Posted: December 14, 2018, 12:00 am
The Medicines Company today announced that it has priced its private offering of $150 million in aggregate principal amount of its convertible senior notes due 2024.
Posted: December 14, 2018, 12:00 am
Days after Axovant announced an end to focusing on its legacy small molecule portfolio in favor of gene therapies, the company announced it has licensed worldwide rights to two gene therapy programs from the University of Massachusetts School of Medicine.
Posted: December 14, 2018, 12:00 am
Researchers at UCSF recently published research in the journal Science describing their use of a modified version of CRISPR gene editing to stimulate the activity of certain genes, resulting in the prevention of severe obesity in mice who had a genetic predisposition to extreme weight gain.
Posted: December 14, 2018, 12:00 am


This does not augur well for drug companies that, some might argue, have grown addicted to price increases.
Author: Ed Silverman
Posted: December 14, 2018, 7:10 pm
They call her the "young miracle." A baby who was admitted to an Ebola treatment center just six days after birth is now recovered from the virus.
Author: Associated Press
Posted: December 14, 2018, 4:29 pm
Last winter’s dreadful flu season may have had a silver lining: Flu vaccine uptake rose sharply this fall in both children and adults.
Author: Helen Branswell
Posted: December 14, 2018, 4:00 pm
Everyone wants to know who is coming and going.
Author: Ed Silverman
Posted: December 14, 2018, 3:27 pm
Four former employees and an owner of the New England Compounding Center were convicted on charges including mail fraud and conspiracy to defraud the U.S.
Author: Ed Silverman
Posted: December 14, 2018, 2:33 pm

Human Resources

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Posted: December 31, 2018, 5:58 pm

The decision is an example of the case-by-case nature of ADA decisions, especially for employers in the healthcare industry.

Posted: December 14, 2018, 3:12 pm

Despite the rise of AI-related jobs, the largest gaps surround skills like leadership, communication and time management, a LinkedIn report shows. 

Posted: December 14, 2018, 2:49 pm

Some say the annual review is on life support, but is it worth saving?

Posted: December 14, 2018, 2:28 pm

Courts generally consider delays in ADA's interactive process in context.

Posted: December 14, 2018, 2:06 pm