Devices
Edwards Lifesciences has recalled its EV1000A, EV1000NI, EV1000CS EV100 Clinical Platforms due to the potential for fluids to leak into the AC power outlet. The devices are used to monitor patients’ blood pressure and pulse during and after surgery. “Use of these products can result in electrical short circuit, which
FDA Policy/General
Federal Register notice: FDA has determined that the regulatory review period for Edwards Lifesciences’ Edwards Intuity Elite Aortic Valve is 1,508 days, which includes 1,203 days that occurred during the testing phase and 305 days during the approval phase. The device is indicated for the replacement of diseased,
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Section 503A Bulks List Final Rule Questions and Answers.” The document is intended to help small businesses better understand and comply with the final rule establishing the list of bulk drug substances that can be used in compounding. On
Devices
FDA has cleared a CD Diagnostics de novo marketing request for the Synovasure Lateral Flow Test Kit to serve as an aid for detecting periprosthetic joint infection (infection around a joint replacement) in the synovial (lubricant) fluid of patients being evaluated for revision surgery, which is surgery performed to replace
Drugs
Three researchers say that despite increasing interest in use of real-world evidence (RWE), there is no standard definition of the term that has been uniformly embraced. Writing online in JAMA Oncology, the researchers say FDA defines RWE as “data regarding the usage, or the potential benefits or risks of
Drugs
Former FDA commissioner Scott Gottlieb has returned to the venture capital firm he was at just before being appointed to the agency’s top post in 2017 — New Enterprise Associates (NEA). Previously at NEA for 10 years as a venture partner, Gottlieb returns as a full-time investing partner on
FDA Policy/General
Federal Register notice: FDA has announced an amendment to a 4/24 Federal Register notice about a 5/30-31 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting. The amendment notes that the meeting will be held on 5/30/2019, from 9 am to
Drugs
The Lower Health Care Costs Act of 2019, bipartisan legislation released for comment by the Senate HELP Committee, includes more than 30 specific provisions, including some affecting FDA, to reduce the costs Americans pay for health care. Last year, the committee asked the American Enterprise Institute, Brookings Institution, governors, state
Devices
FDA has approved a Novocure humanitarian use device for NovoTTF-100L System in combination with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM). NovoTTF-100L is an antimitotic cancer treatment that delivers “tumor treating fields” to the tumor
Devices
FDA says it has cleared a modified Erbe USA Erbeflo port connector to help reduce risk of endoscope cross-contamination. An agency notice says the design of the modified Erbeflo 24-hour use port connector added a backflow prevention feature as recommended in FDA guidance for reducing the risk of
Devices
FDA has issued a safety alert on a Class 1 recall of Beckman Coulter’s DxH 800, DxH 600 and DxH 900 hematology analyzers, which perform blood tests to diagnose diseases and conditions such as anemia, infections, blood clotting problems, blood cancers and immune system disorders. The agency says the
FDA Policy/General
A House Agriculture subcommittee has voted to advance a fiscal year 2020 spending bill that would increase FDA’s budget authority by 6% ($184 million) over FY 2019 levels. A House combined press release and statement said: “The FDA receives a total of $3.26 billion in discretionary funding in
Drugs
FDA has released the FDA-483 issued following a 5/6-5/15 inspection at Lupin, Ltd., Aurangabad, Maharashtra, India. The form’s inspection observations for the manufacturer of finished drugs were: 1. written records of investigations into unexplained discrepancies and the failure of a batch or any of its
Devices
FDA has cleared a Roche 510(k) for the cobas TV/MG test for use on the cobas 6800/8800 Systems for detecting Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA in both symptomatic and asymptomatic patients. The expanded clearance now permits laboratories to simultaneously process from a single patient
Drugs
AstraZeneca says an FDA draft guidance on bioavailability (BA) studies submitted in NDAs and INDs mentions bioequivalence several places in the document. The company’s comment letter says “if demonstration of bioequivalence is not a requirement, we suggest replacing ‘BE studies’ with ‘BA studies’ in this guidance. It is appreciated
Drugs
The Justice Department has filed a complaint in a New York federal court seeking a permanent injunction against Confidence USA, Port Washington, NY, and its president and manager, to prevent them from marketing dietary supplements without following current good manufacturing practices. A department news release says FDA inspections repeatedly showed
Drugs
The Office of Management and Budget Spring 2019 Rule List includes 80 proposed and final stage rules from FDA. The HHS listing includes 61 regulations in the proposed rule stage for FDA-regulated products, and 19 at the final rule stage.
FDA Policy/General
Federal Register notice: FDA has released a draft guidance on “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.” The document describes the agency’s recommendations on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed therapeutic protein product
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of 24 ANDAs from multiple applicants. The applicants notified the agency that the drug products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
Devices
Johnson & Johnson says that an FDA proposal to post a list of devices relying on predicates older than a specified number of years is “built on a lack of evidence that age of predicate is a substantial indicator of medical device innovation.” Commenting on agency proposals to modernize the
Drugs
FDA has accepted for review an Agile Therapeutics NDA resubmission for Twirla (ethinyl estradiol and levonorgestrel transdermal system), an investigational low-dose combined hormonal contraceptive patch. The original NDA received a complete response letter 12/2017 that, according to the company, identified deficiencies relating to (1) quality control adhesion test
Devices
FDA says it is looking for test cases from software organizations planning to submit a de novo request or 510(k) submission for software as a medical device to meet the goals of the software precertification program. An agency notice says volunteers are sought representing a broad spectrum of software