Devices
A year after Bayer stopped selling and distributing Essure, an implantable contraceptive device, CDRH director Jeff Shuren says the company has repossessed 99% of unused devices in the market. “Additionally, postmarket safety monitoring for women who have Essure implanted remains a top priority for the agency, and today we are
FDA Policy/General
Federal Register notice: FDA has announced a 2/4 public meeting entitled “Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc.” The meeting is intended to discuss and obtain scientific information on topics related to testing methodologies, terminology, and criteria that can be applied to characterize and measure
Biologics
FDA has granted Meissa Vaccines a fast track designation for MV-012-968, an investigational, live attenuated vaccine for protection against respiratory syncytial virus (RSV) infection. RSV is the most common cause of acute lower respiratory tract infections in young children and infects nearly all children by two years of
Devices
FDA has granted Reflow Medical a breakthrough device designation for the Temporary Spur Stent System, a novel retrievable stent technology intended for treating below-the-knee (BTK) peripheral artery disease. The combination device comprises a “patented retrievable stent system having a series of radially expandable spikes designed to create multiple
Devices
FDA has approved a MicroVention PMA for the FRED (Flow Re-Direction Endoluminal Device) device for treating brain aneurysms. The company says this is the first flow diverter in the U.S. to use a self-expanding braided nitinol mesh to help re-direct blood flow and promote aneurysm occlusion.
Drugs
The Coalition to Preserve Access to Pharmacogenomics (PGx) Information has petitioned FDA urging it to stop enforcement actions against genetic tests that claim to predict a patient’s response to specific medications. Over the past year, the agency has warned several companies about claims made for specific genetic tests. It
Drugs
Alnylam Pharmaceuticals has begun a rolling submission of its NDA for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase for treating primary hyperoxaluria Type 1 (PH1). Specifically, the company submitted non-clinical components and it expects to submit the remaining components later this year 2020. Alnylam also says it has
FDA Policy/General
Federal Register notice: FDA is proposing to withdraw approval of 249 ANDAs from multiple companies because they have repeatedly failed to file required annual reports for the applications. The ANDA holders are being offered an opportunity to request a hearing on the withdrawal proposal and they have until 2/10
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Human Tissue Intended for Transplantation — 21 CFR Part 1270” (OMB Control Number 0910-0302). FDA regulations require written procedures to be prepared and followed, and require records to be maintained concurrently with the performance of each significant
Drugs
Researchers from the University of Michigan and Harvard Medical School say that Reckitt Benckiser earned at least $1 billion in extra profits by exploiting various FDA regulatory procedures to impede the entry of generic competitors and maintain elevated prices for its Suboxone (buprenorphine), used to treat opioid use disorder. Writing
FDA Policy/General
FDA, the Department of Agriculture, and the Environmental Protection Agency have launched a unified Web site for biotechnology regulation to streamline information about the three regulatory agencies charged with overseeing agriculture. An FDA statement said the Web site is part of President Donald Trump’s executive order on modernizing the
Devices
CDRH scientists and engineers have developed a new tool to help hospitals determine how clean an endoscope is after it has been reprocessed. The effort is being led by the Center’s Biofilms Research Group and the Office of Science and Engineering Laboratories. Studies at hospitals are underway to confirm
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision for “General Administrative Practice and Procedures” (OMB Control Number 0910-0191). FDA says it has reviewed its regulations and is revising the collection to include provisions that it believes may be subject to OMB review. To view the
Drugs
A study funded by Pharmaceutical Research and Manufacturers of America says that it is a misconception that manufacturers retain the vast majority of drug spending. In fact, the study says, despite absolute growth in brand medicine spending at the point of sale, which increased from $354 billion in 2015 to
Devices
FDA has cleared a Penumbra 510(k) for an expanded indication for its Indigo Aspiration System — treating pulmonary embolisms. Previously, the device was cleared for removing fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. The company says it uses its proprietary Penumbra Engine aspiration
Drugs
FDA says Appco Pharma and Denton Pharma (doing business as Northwind Pharmaceuticals) are recalling prescription ranitidine (Zantac) tablets because they may contain unacceptable levels of N-nitrosodimethylamine (NDMA). An agency recall notice says FDA has advised companies to recall ranitidine if testing shows NDMA levels above the acceptable daily intake
Drugs
Regeneron says results from the LUMINA-1 Phase 2 trial of its garetosmab in 44 patients with fibrodysplasia ossificans progressiva (FOP) showed about a 25% decrease in total bone lesions (new and existing) driven by a nearly 90% reduction in the formation of new lesions. A company statement says Regeneron
FDA Policy/General
Google says it will make the FDA open-source MyStudies platform available on its Google Cloud platform to “stimulate an open ecosystem that will improve the ability of organizations to perform research that leads to better patient outcomes.” Health IT News reports that FDA developed MyStudies to help researchers manage
Drugs
FDA has approved a Blueprint Medicines NDA for Ayvakit (avapritinib) for treating adults with unresectable or metastatic gastrointestinal stromal tumors (GIST) that have a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation. Ayvakit is a kinase inhibitor, which blocks a type of enzyme called a kinase and helps
FDA Policy/General
Federal Register notice: FDA has announced a 3/27 public meeting entitled “Modernizing FDA’s Data Strategy,” which will discuss possible agency-level approaches to modernizing FDA’s data strategy, including approaches to data quality, data stewardship, data exchange, and data analytics. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has extended until 1/24 the comment period for a draft guidance entitled “Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff.” The guidance reflects revised statutory provisions for requesting certificates under the 21st Century Cures Act. The certificates
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension on “Focus Groups as Used by the Food and Drug Administration (All FDA- Regulated Products)” (OMB Control Number 0910–0497). Focus groups play an important role in gathering information because they allow for a more in-depth understanding