This article presents some key points for consideration regarding the establishment of a dedicated and centralized regulatory intelligence department.   Keywords – centralized, dedicated department, regulatory intelligence   Introduction Regulatory intelligence has become an increasingly important component of regulatory affairs as the global landscape expands and changes, and professionals and businesses must adapt rapidly to remain current and viable. I...

The US Food and Drug Administration (FDA) on Wednesday announced it has cleared a next-generation sequencing (NGS) test developed by Memorial Sloan Kettering Cancer Center (MSK) that can detect 468 unique gene mutations and other molecular biomarkers in a patient's tumor. The test, referred to as MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets), was already approved for use with samples from patients in New York by the New York State Department of ...

The House of Representatives' Rules Committee on Monday will take up a provision that would expand the US Department of Defense's (DoD) ability to approve, on an emergency basis, medical products, as US Food and Drug Administration (FDA) Commissioner Scott Gottlieb pushed for the provision to be rejected. According to the committee's conference report on the National Defense Authorization Act for FY 2018, the House will add the Senate amendment to authorize the s...

With more than three million Americans in Puerto Rico facing no electricity because of Hurricane Maria, medical device and biopharmaceutical companies, many of which have manufacturing facilities on the island, are doing what they can to work with the US government to help their employees and restart operations. A spokesman from MedTech industry group AdvaMed told Focus at the group’s MedTech conference in San Jose, California on Monday that the group is working w...

Six former Insys Therapeutics executives and managers were arrested on Thursday on charges that they conspired to bribe healthcare practitioners to prescribe the company's fast-acting fentanyl spray Subsys. Background The US Food and Drug Administration (FDA) approved Subsys in 2012 with a narrow indication for managing "breakthrough pain in adult cancer patients who are already receiving and who are tolerant to around-the-clock opioid therapy for underlying persisten...

A group of 51 lawmakers are calling on the National Institutes of Health (NIH) to issue guidance on when "march-in rights" could be used to bypass patents on drugs developed using federal funding. In a letter led by Rep. Lloyd Doggett (D-TX) to Department of Health and Human Services (HHS) Secretary Sylvia Burwell and NIH Director Francis Collins today, the lawmakers call on NIH to "utilize [its] existing statutory authority to respond to the soaring cost of pharmaceutic...

The governments of the US and China have agreed to several policies that have the potential to reduce barriers to trade for US medical devices and pharmaceuticals sold in China. The agreement comes from discussions between the two countries at the 25th US-China Joint Commission on Commerce and Trade held in Chicago between 16 and 18 December 2014. Less Red Tape China has “agreed to streamline [its] regulatory process and cut red tape” for US pharmaceuticals and medical ...

Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. India’s health ministry, the Department of Health and Family Welfare, will submit proposed changes to the country’s medical device and pharmaceutical laws to Parliament in 2015. The proposed  Drugs and Cosmetics (Amendment) Bill , 2015  would adopt definitions of medical devices as well as in vitro diagnostic (IVD) products more in...

The US Food and Drug Administration (FDA) has granted emergency use authorizations (EUAs) to two new diagnostic tests meant to help health professionals to accurately diagnose the Ebola Zaire virus in record time. Background In March 2013, FDA was given a host of new authorities and responsibilities under the  Pandemic and All-Hazards Preparedness Reauthorization Act  ( PAHPRA ), a piece of legislation intended to bolster the government's ability to respond to health ...

The US Food and Drug Administration (FDA) may be the federal government's regulator of most medical products, but at least one federal agency is looking to conduct basic reviews of the safety and efficacy of one type of medical product FDA says it has the authority to regulate. Background Under normal circumstances, medical devices can reach the market in one of two ways. Either they obtain FDA approval through the premarket approval (PMA) process—a difficult and e...

Regulatory professionals frequently work with their supply chain colleagues to ensure all relevant documentation is provided for the export of goods from the country of origin. However, there are little-known US regulatory requirements with potentially significant administrative and criminal consequences for violation, and many manufacturers may not be aware of them. The US Departments of Commerce, State and the Treasury publish lists of US and international individuals a...

US pharmaceutical manufacturer Merck & Co. has settled criminal charges over the company's marketing of its painkiller drug Vioxx, reports Bloomberg . Merck will pay a $321.6 million criminal fine after US District Judge Patti Saris approved the settlement. This fine is in addition to a $628.3 million in civil claims paid out in November 2011, reports The Philadelphia Inquirer . Merck was charged with promoting Vioxx, a rheumatoid arthritis drug, illegally despite...