FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.” The document provides detailed recommendations for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers, and includes guidance describing the types of modifications to a diagnostic ultrasound device for which
FDA Policy/General
Federal Register notice: FDA is seeking public comment on its Clinical Data Summary Report Pilot program as part of the agency’s continuous assessment of the efficiency and transparency of the clinical data used in regulatory decision making. The Agency is also seeking public feedback on a new integrated review
Devices
An online Kaiser Health News post lists five key items the service found in its review of a recently published FDA “alternative summary” database often used by medical device manufacturers to report injuries or malfunctions, bypassing the public MAUDE database used by doctors, researchers, and patients. The news service says
Devices
FDA says 11 Medtronic MiniMed and MiniMed Paradigm insulin pumps have potential cybersecurity risks and diabetes patients using the specific models should switch their insulin pump to models that are better equipped to protect against the potential risks. An FDA safety communication lists the 11 affected models and offers recommendations
Drugs
Under a contract with CDER, EdjAnalytics, a data science firm providing artificial intelligence, machine learning and advanced analytics for life sciences, has developed a predictive model to support the agency’s decision-making process to select manufacturing sites for inspection. “The model provides the likelihood of a facility having an
Devices
Vyaire Medical has recalled its enFlow Fluid Warming System disposable cartridges due to the potential for aluminum to elute from the warmer into the fluids, which could expose patients to unsafe levels of aluminum. “Exposure to unsafe levels of aluminum may result in serious adverse health consequences including, but not
Drugs
Durect has submitted a detailed reply to an FDA 2014 complete response letter for Posimir (bupivacaine extended-release solution), a post-operative pain relief depot product that uses the company’s Saber technology. The product is designed to be administered directly into a surgical site to deliver bupivacaine for up
Drugs
Members of the congressional Problem Solvers Caucus, 23 Democrats and 23 Republicans from both the House and the Senate, have released a list of seven principles for supporting prescription drug pricing legislation. A media statement from Sens. Susan Collins (R-ME) and Joe Manchin (D-WV) said legislation to address
FDA Policy/General
FDA is proposing research into disease awareness and prescription drug communications on television. A Federal Register notice says that when drug companies market a new drug, they often also release disease awareness communications about the medical condition the drug is intended to treat. The CDER Office of Prescription Drug Promotion
FDA Policy/General
The U.S. Supreme Court 6/24 delivered a 6-3 decision that will make it easier for FDA and other government agencies to shield companies’ supposed commercial/confidential information from disclosure under the Freedom of Information Act (FOIA). Writing in a 6/26 FDA Law Blog post, Hyman, Phelps
Biologics
CBER has released a list of 20 guidances it is considering for development in this calendar year. The notice says the list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CBER has already issued Level 1 draft
Drugs
FDA has expanded the approval of Regeneron’s Dupixent (dupilumab) for use with other medicines to treat chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. CRSwNP can be a debilitating condition, with many patients opting for systemic steroids or nasal surgery. The condition alos often
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Clinical Investigations for Prostate Tissue Ablation Devices.” The document provides recommendations for clinical investigations for high intensity ultrasound systems for prostate tissue ablation and new types of prostatic tissue ablation devices. To view the notice, click here.
Drugs
FDA will receive feedback for 60 days on its Clinical Data Summary Report pilot program that is part of an effort to increase the transparency of the clinical data used in the regulatory decision-making process. A Federal Register notice says the agency also wants public feedback on a new
Devices
FDA has published a guidance, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, with recommendations for manufacturers seeking marketing clearance for diagnostic ultrasound systems and transducers. In addition to outlining regulatory approaches for certain diagnostic ultrasound devices, the document describes the types of modifications to a diagnostic ultrasound device for
FDA Policy/General
FDA has released a draft guidance entitled “E19 Optimization of Safety Data Collection.” The document is intended to provide internationally harmonized guidance on when it would be appropriate to use a selective approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such
Devices
FDA has issued a draft guidance, Clinical Investigations for Prostate Tissue Ablation Devices, with recommendations for (1) complying with the clinical testing special control for 510(k)s for high-intensity ultrasound systems for prostate tissue ablation, and (2) collecting clinical data to support marketing submissions for new types of
Drugs
Federal Register notice: FDA is seeking comments on an information collection extension related to a guidance on “Administrative Procedures for Clinical Laboratory Improvement Amendments (CLIA) Categorization — 42 CFR 493.17 (OMB Control Number 0910-0607)." The guidance describes procedures FDA uses to assign the complexity category to a device,
Drugs
A bipartisan group of House lawmakers has introduced legislation to make more over-the-counter (OTC) medications available to patients. The Over-the-Counter Monograph Safety, Innovation, and Reform Act was spearheaded by Reps. Diana DeGette (D-CO), Bob Latta (R-OH), Debbie Dingell (D-MI) and Brett Guthrie (R-
Drugs
A 1/28-2/1 FDA inspection at Rxhomeo Private Limited, Hyderabad, Telangana, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 6/13 Warning Letter says the violations were: * failing to test samples of each component for identity and conformity with all appropriate
Devices
FDA has cleared a Viveve Medical 510(k) for the company’s next-generation Viveve 2.0 cryogen-cooled monopolar radiofrequency system for use in general surgical procedures for electrocoagulation and hemostasis. The company says its device’s controlled cooling protects the tissue surfaces from any damage and impacts the
Biologics
A Florida federal court 6/25 has issued an order that stops U.S. Stem Cell Clinic, of Weston, FL, and U.S. Stem Cell Inc., of Sunrise, FL, and their chief scientific officer Kristin Comella, from manufacturing or distributing any and all stromal vascular fraction products, which are adipose