FDA Policy/General
DEVICES FDA has cleared an ACell, Inc. 510(k) for its MicroMatrix device and its concurrent use with Cytal Wound Matrix or Cytal Burn Matrix devices. The micronized particulate form of ACell’s patented Urinary Bladder Matrix technology provides coverage of the wound bed, especially in irregular wounds. It provides
Devices
FDA has issued a safety alert warning patients and health care professionals about risks associated with using unapproved or unauthorized devices for diabetes management, including continuous glucose monitoring systems, insulin pumps and automated insulin dosing systems. The alert notes that the use of unapproved or unauthorized devices could result in
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Applications for Food and Drug Administration Approval to Market a New Drug: Patent Submission and Listing Requirements” (OMB Control Number 0910-0513). The federal Food, Drug, and Cosmetic Act requires all NDA applicants to file, as part
Devices
FDA has cleared a Flat Medical 510(k) for its EpiFaith syringe to deliver safe epidural locating solution. Compared with traditional practice that relies on a manual sense, EpiFaith provides an “intuitive signal” that alerts anesthesiologists when it has arrived in the epidural space, according to the company. The device
FDA Policy/General
Federal Register notice: FDA is correcting a 4/12 Federal Register notice on the classification of medical device accessories distinct from other devices, which included a finalized list of accessories suitable for Class 1. That notice was published with the instruction to add a section to the incorrect subpart. To
Drugs
AbbVie has stopped a Phase 3 study called INTELLANCE-1 that was evaluating depatuxizumab mafodotin in patients with newly diagnosed glioblastoma (GBM), whose tumors have EGFR (epidermal growth factor receptor) amplification, based on data that demonstrated no survival benefit for treated patients. An interim analysis by the company’s independent
Drugs
FDA says it inspected 26% (739) of the 2,852 foreign-based human drug manufacturing sites outside of the U.S. in fiscal year 2018. In a 5/17 agency post, FDA provided a glimpse into its recent drug inspection activities. “As of fiscal year 2018, there were 4,676
Drugs
FDA has approved a Takeda Pharmaceuticals supplemental NDA to expand the indication for Gattex’s (teduglutide) for injection to pediatric patients aged one year and older with short bowel syndrome who need additional nutrition or fluids from intravenous feeding (parenteral support). Approval was based on data from a 24-week
Devices
The Justice Department and CDRH director Jeffrey Shuren say Carefusion Corp., San Diego, CA, will pay $3.3 million to the federal government to resolve charges that it bought and sold medical devices that were not cleared or approved by FDA. A Justice Department statement says the unapproved devices were
Drugs
Three researchers say effort needs to be increased to incorporate patient-reported outcomes (PROs) as a data source for real-world evidence. Writing online in the journal Nature Reviews Drug Discovery, the researchers say that as pressures from legislation, international regulatory authorities, and patient groups promote more patient-centric drug
Drugs
FDA has approved an EMD Serono and Pfizer NDA for Bavencio (avelumab) in combination with Pfizer’s Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This is the first FDA approval for an anti-PD-L1 therapy as part of a combination regimen
Drugs
FDA has approved a Pfizer sNDA for Fragmin (dalteparin sodium) subcutaneous injection to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients aged one month and older. VTE includes deep vein thrombosis and pulmonary embolisms, an agency release says. “Most children who have VTE are fighting a serious
Devices
Ethicon has recalled its Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples and Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples due to insufficient firing, which can compromise staple line integrity. According to a recall notice, surgeons use the devices in the “gastrointestinal tract for creating connections
Drugs
Iqvia Institute for Human Data Science says that over the next five years, clinical trial productivity will be heavily influenced by trends like biomarkers, pre-screened patient pools, and predictive analytics. The projection is in a white paper, “The Changing Landscape of Research and Development.” The analysis indicates that ongoing
Drugs
University of Florida researchers are working with CDER’s Office of Generic Drugs to develop an integrated bioinformatics approach to investigate potential claims of oral generic drug product bioinequivalence. A study report in the Journal of Clinical Pharmacology says that in the GDUFA 2012 letter of commitment, FDA committed to
Devices
FDA has cleared a Masimo 510(k) for the Radius PPG, a tetherless sensor associated with the Masimo SET patient monitor. The sensor eliminates the need for a cabled connection to a pulse oximetry monitor, allowing patients to move freely while still being continuously monitored. Through a wireless connection, measurements
Devices
FDA has cleared a GenePOC 510(k) for the Carba assay and its use with the Revogene device to detect carbapenem-producing organisms (CPO). CPOs are known to be resistant to commonly used antibiotics and occasionally completely resistant to all available antibiotics, the compamy says. The qualitative, in vitro diagnostic
FDA Policy/General
Consumers are likely to be confused if the Centers for Medicare and Medicaid Services goes ahead with its rule requiring drug companies to show in TV ads the list price of all medicines covered by Medicare or Medicaid that cost $35 or more for a one-month supply or a
Drugs
Pfizer says it supports risk-based approaches to clinical trial monitoring that can realize new efficiencies and facilitate strategies for clinical trial design and conduct. In comments on an FDA draft guidance on a risk-based approach to monitoring of clinical investigations, the company commends the authors of the guidance
Drugs
FDA has cleared an Aidoc 510(k) for its pulmonary embolism (PE) artificial intelligence (AI) product that helps radiologists flag and triage PE cases in chest computerized tomography scans. The company’s AI analyzes medical images directly after the patient is scanned and notifies radiologists on cases with suspected findings
Drugs
The Justice Department says FDA “lacks jurisdiction” to regulate articles, including drugs, intended for use in lawful executions. An opinion from the department’s Office of Legal Counsel says the agency has not historically exercised jurisdiction over articles intended to carry out a lawful sentence of capital punishment. Federal court
Devices
Commenting on an FDA request for comments on modernizing the 510(k) program, AdvaMed says it supports the current program, which includes the ability to use older legally marketed devices as predicates, to the extent substantial equivalence can be demonstrated. “The 510(k) program has demonstrated its effectiveness and durability