A Utah-based manufacturer and seller of herbal remedies and nutritional supplements has agreed not to market or sell its wares until products and labeling are compliant with federal drug regulations. Acting on behalf of the US Food and Drug Administration (FDA), the Department of Justice filed the complaint that triggered the consent degree of permanent injunction between Grandma’s Herbs, Inc., its owners, and the US government. The consent decree was entered by the US Dis...

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Tavneos okayed for ANCA-associated vasculitis ChemoCentryx’s Tavneos (avacopan) has been approved as an adjunctive treatment for adults with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis, also known as ANCA-associated vasculitis, in combination with standard therapy.   ANCA-associated vasculitis is a group of thr...

TGA releases guide to classifying active medical devices by risk   New guidance from Australia’s Therapeutic Goods Administration (TGA) on the risk classification of active medical devices covers software-based products and other medical devices that act by converting energy. Examples of covered devices include pacemakers and phototherapy devices.   The EU defined the term “active medical device” in its Medical Device Regulation (MDR). TGA, which follows the EU w...

The European Medicines Agency (EMA) recently released its final programming document for 2021 to 2023, setting goals to address medicine availability and shortages, analysis and access to healthcare data, supply chain issues, and antimicrobial resistance.   Emer Cooke, EMA Executive Director, stated in the document’s foreword that much of the agency’s planning over the next few years will be accomplished by implementing the EMA Network Strategy and Regulatory Science S...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency ( FDA ) FDA still without a permanent leader as clock ticks down on acting head ( CNN ) IPO floodgates open up after summer lull as five more biotechs file for Nasdaq ( Endpoints ) FDA staff doesn’t take stance on Moderna Covid booster shots, says two doses are...

A new pilot program from the US Food and Drug Administration (FDA) dedicated to reviewing quality and toxicology data for novel drug excipients is aimed at speeding drug development by providing an easier pathway for the agency to qualify these ingredients.   “In some cases, FDA may find issues with the excipients used in a drug development application, which can affect and even delay the application,” explained FDA official Karen Davis Bruno, associate director of pha...

The U.S. Food and Drug Administration (FDA) launched its accelerated approval program in 1992, offering a pathway to bring life-saving drugs and biologics to the market faster. After nearly 30 years, could substantial reforms be on the way?   At RAPS Convergence 2021, David Dorsey of Janssen R&D, said Congress could choose to make changes to the accelerated approval program through the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA). Congress has...

A new electronic information system for clinical trial reporting in the EU is one step closer to launch with the European Medicines Agency’s (EMA’s) Thursday publication of a go-live planning document.   The 12-page document covers key steps remaining before the launch of the Clinical Trial Information System (CTIS), planned for 31 January 2022, and follows an April 2021 audit by EMA’s management board that confirmed that CTIS is “fully functional and meets the agreed ...

The U.S. Food and Drug Administration has released draft guidance for clinical trial investigators outlining their safety reporting duties for investigational drugs and devices.   The draft , published on 29 September 2021, is focused exclusively on the role of investigators – not sponsors – and merges past final guidance from 2009 and 2012 on safety reporting that was previously mixed in with advice to sponsors. The prior guidance will remain in effect until the new ...

The European Medicines Agency (EMA) has identified a need for more consistency in how real-world evidence (RWE) is submitted, Xavier Kurz told attendees at RAPS Convergence 2021.   Kurz, the head of surveillance and epidemiology at EMA, said the agency reached the conclusion after analyzing the use of RWE in applications for marketing authorization and extension of indication in 2018 and 2019. The study, preliminary findings from which were shared at RAPS Convergence 2...

The US Food and Drug Administration (FDA) has launched a new pilot program to review novel excipients for use in meeting unmet needs in formulating new drug products. The pilot has the full support of the pharmaceutical industry.   FDA called the program “a new pathway for manufacturers to obtain FDA review of certain novel excipients (inactive ingredients) prior to their use in drug formulations,” according to a 7 September announcement.   Excipients are inactiv...

Craig Martin is chief executive officer of Global Genes, a nonprofit organization whose mission is to increase public awareness for rare disease and globally connect, empower and educate individuals and rare disease foundations in person, print and online. More than 400 million people worldwide are affected by 7,000+ rare diseases. In the U.S., around 1 in 10 people (more than 33 million Americans) have a rare condition. More than half of rare disease patients are chi...