Regulatory Focus

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Regulatory Focus

 •  January 16

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday reassured drugmakers that there will be no sudden changes to the country's regulatory framework when it leaves the EU in March 2019. In December, the UK and European Council agreed to advance Brexit negotiations to a second phase , and adopted guidelines for the...

Regulatory Focus

 •  January 16

The US Food and Drug Administration (FDA) on Tuesday proposed a new rule for appealing certain decisions about medical devices made by the Center for Devices and Radiological Health (CDRH). The proposed rule is in line with legislative requirements established by the Food and Drug Administration Safety and Innovation Act(FDASIA) and 21st Century...

Regulatory Focus

 •  January 15

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) last month released details on its upcoming voluntary medical device manufacturing and product quality pilot program as part of its Case for Quality (CfQ) initiative. "CDRH envisions a future state where the medical device ecosystem is inherently focused...

Regulatory Focus

 •  January 11

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Swissmedic Updates Biosimilar Guidance to Allow Comparators of US Origin The Swiss Agency for Therapeutic Products (Swissmedic) has liberalized its rules on the comparators used in biosimilar clinical trials. Swissmedic is now allowing biosimilar...

Regulatory Focus

 •  January 11

The International Coalition of Medicines Regulatory Authorities (ICMRA) has its eye on aligning existing and planned track and trace systems worldwide, with a focus on interoperability as many of the existing and planned systems were designed with a national or regional focus. Track and trace systems, which have been or are currently being...

Regulatory Focus

 •  January 10

Each year, the US Food and Drug Administration (FDA) designates anywhere from dozen to hundreds of medical device recalls as Class I, indicating that the risk addressed by the recall could potentially cause serious injury or death. But it can be difficult to quantify the number of device recalls in a year, given the multiple data sources from FDA,...

Regulatory Focus

 •  January 4

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Ireland Offers to Waive Certain Fees to Ease Impact of Brexit Ireland is offering to waive the fee for certain Brexit-triggered regulatory requests. The offer will allow companies to change their reference member state (RMS) from the United Kingdom to...

Regulatory Focus

 •  January 4

The US Food and Drug Administration (FDA) on Wednesday warned stem cell product supplier American CryoStem Corporation for marketing an unapproved product after the agency inspected the company's Eatontown, New Jersey site in July. The warning letter comes just months after FDA announced a new framework for regulating regenerative medicines that...

Regulatory Focus

 •  January 3

In the last days of 2017, the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued a warning letter to over-the-counter (OTC) drugmaker Avanthi, Inc. for omitting risk information in a panel for the weight loss drug Lomaira (phentermine hydrochloride USP). The warning letter brings the total number of...

Regulatory Focus

 •  January 2

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US After Hurricane Maria, IV bags are still in short supply (Newsweek) FDA chief: I'm surprised it took big tech this long to get into health care (CNBC) Trump FDA Chief Scott Gottlieb Isn't Pharma's BFF After All (Bloomberg) Toward Better-Quality...