This article details how regulatory intelligence can help medtech companies assess the impact of the new EU legislative framework for in vitro diagnostics (IVDs). Using the example of COVID-19 antigen tests, the author looks at how regulatory intelligence helped device manufacturers manage the changes in regulations during the pandemic and how the lessons learned can support the industry in assessing and planning for the impact of the new legislative framework for IVDs tha...

The US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) on Monday issued a draft guidance that provides generic drug applicants with answers to commonly asked questions in the drug quality area. The new guidance is designed to provide an immediate response to such questions to reduce the number of controlled correspondence on identical topics.   The guidance, which is in a question-and-answer format, covers FDA’s policies on quality...

This article provides an overview of class action lawsuits targeting the dietary supplement industry. Recent trends indicate that companies should look beyond regulatory compliance and consider how a “reasonable consumer” would interpret claims in labeling, even claims that comply with FDA requirements. There are also important steps companies can take to prevent these lawsuits, as well as defenses that courts seem increasingly willing to accept. By staying aware of the cl...

Thanks to the 21st Century Cures Act , the US Food and Drug Administration (FDA) on Thursday proposed to exempt additional class II medical devices under five different product codes from 510(k) requirements. The proposed exemptions follow the finalization of a list in July 2017 of 1,003 types of class II devices that the agency also said do not present risks that require premarket notification. But for four of the five product codes proposed on Thursday, FDA has ...

Last month, Edwards Lifesciences recalled its SAPIEN 3 Ultra Delivery System after reports of burst balloons during implantation, resulting in significant difficulty retrieving the valve into the catheter and withdrawing the system from the patient, the US Food and Drug Administration (FDA) said Thursday. FDA said 17 injuries and one death were reported at the time when Edwards initiated the Field Corrective Action early last month. “The use of affected product may caus...

The US Food and Drug Administration (FDA) on Monday revised its guidance on the electronic common technical document (eCTD) format to note specific cases where the agency believes a submission should be exempted or granted a waiver. As far as what submission types warrant an exemption from eCTD requirements, FDA points to Type III drug master files (DMFs), which provide information on packaging or packaging materials in support of drug, generic drug or biologic applicat...

The US Food and Drug Administration (FDA) on Friday announced that Indian drugmaker Hetero Labs is recalling 87 lots of losartan tablets distributed by Camber Pharmaceuticals after testing found the drugs contained a potentially carcinogenic impurity, N-Nitroso-N-methyl-4 aminobutyric acid (NMBA).   The recall is the latest in a series of recalls tied to the discovery of nitrosamine impurities in angiotensin II receptor blocker (ARB) drugs in the last year.   Previ...

In the pharmaceutical industry, complete response letters, or rejections, are a common occurrence. And though they aren’t frequently explained in detail publicly, the public is still usually notified that the company has received such a letter. But in the world of medical devices, failing to win approval for a high-risk device is a much more closely held secret, and companies can withdraw their applications rather than be denied approval.   A Federal Register notice ...

The US Food and Drug Administration (FDA) said Friday that it will delay its enforcement of certain unique device identification (UDI) system requirements for class I and unclassified devices by two years. A Federal Register notice on guidance released Friday, which FDA said takes effect immediately, said: "FDA does not intend to enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements under Ag...

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, including a listing of annual Class I and other significant recalls , a device recalls database and a data dashboard . B...

The US Food and Drug Administration (FDA) on Friday published draft guidance that would establish a new type of letter the agency sends to generic drugmakers to provide applicants with preliminary thoughts on possible deficiencies of an abbreviated new drug application (ANDA). Thanks to the recently reauthorized Generic Drug User Fee Amendments (GDUFA II), FDA will issue Deficiency Review Letters (DRLs) and information requests (IRs) to obtain further information ...

The US Food and Drug Administration (FDA) last month began releasing new information a monthly basis related to generic drugs. Whereas in previous years, the agency released monthly statistics on 12 different categories related to FDA’s review of abbreviated new drug applications (ANDAs), now the agency releases monthly data on 30 different categories. The new categories will shine a light on metrics where the generics industry has struggled in recent years, like...