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 In comments on an FDA draft guidance on a risk-based approach to monitoring of clinical investigations, the company commends the authors of the guidance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
Drugs
The Pew Charitable Trusts says it supports the bipartisan Over-the-Counter Monograph Safety, Innovation, and Reform Act to modernize the monograph system by eliminating what it says is the “burdensome” rule-making process for changing monographs and expand FDA funding through user fees paid by manufacturers of over-the-
Drugs
FDA’s Oncologic Drugs Advisory Committee has voted 3 to 8 not to recommend approval of a Daiichi-Sankyo NDA for quizartinib, indicated for treating adults with relapsed or refractory acute myeloid leukemia (AML) which is FLT3-ITD positive, as detected by an FDA-approved test. Panel members appeared to
FDA Policy/General
Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances that provide product-specific recommendations on, among other things, bioequivalence study designs to support ANDAs. To view the notice, click here.
Devices
FDA has approved a W. L. Gore PMA for the Gore Tag Conformable Thoracic Stent Graft with Active Control System, an endovascular aortic repair device. The device and delivery system is designed to provide new precision and predictable patient outcomes in the endovascular repair of aneurysms, transections, and Type B
Drugs
FDA has approved a Genentech supplemental NDA for Venclexta (venetoclax) in combination with the company’s Gazyva (obinutuzumab) for treating people with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Approval is based on data from the Phase 3 CLL14 study, which evaluated a 12-month, fixed-duration treatment
Drugs
A class action suit has been filed against Gilead, Bristol-Myers Squibb, Japan Tobacco (Akros Pharma), and Janssen for engaging in a “long-running scheme to restrain competition with respect to some of the most important drugs used to treat HIV/AIDS.” The suit says that through an array of
Devices
FDA has updated its Essure Web page with information on medical device reports about Essure received in 2018. The agency says it continues to post the latest information about Bayer’s postmarket surveillance study on the 522 study Web page. The company withdrew Essure from the market at the end
Drugs
Janssen says it recognizes and appreciates FDA efforts to issue a draft guidance related to quality considerations for continuous manufacturing. In a comment letter, the company says it supports the draft guidance content and believes that once it is finalized, all stakeholders will receive significant benefits. The letter lists several
Drugs
A 12/17-12/21/18 FDA inspection at Petra Hygienic Systems International, Concord, Ontario, Canada, found repeat current good manufacturing practice (CGMP) violations in the firm’s manufacturing of finished pharmaceuticals. A 5/17 Warning Letter says the inspection observations were: * failing to have, for each batch of drug
Drugs
FDA says it has sent Warning Letters to five companies that produce products labeled as homeopathic for significant violations of current good manufacturing practice regulations. An agency media release says four of the letters pertain to companies that jointly produced a product labeled as homeopathic that posed a significant risk
Drugs
CDER has issued its latest “Report on the State of Pharmaceutical Quality,” a yearly snapshot of the pharmaceutical manufacturing industry’s ability to deliver quality pharmaceutical products. The report says CDER’s Office of Pharmaceutical Quality monitors the quality of CDER-regulated drugs legally marketed in the U.S. It
Devices
Senate HELP Committee ranking member Sen. Patty Murray (D-WA) says data recently released by FDA shows “alarmingly high rates of contamination in certain duodenoscopes, even after the device is cleaned.” In a 5/9 letter to OIympus, she says the data “raise serious questions about your company’s ability
Devices
FDA has cleared an eMurmur 510(k) for the eMurmur ID Solution for detecting heart murmurs. The company says the mobile and cloud device operates in conjunction with a third-party electronic stethoscope. The device is a mobile and cloud solution that analyzes heart sounds to identify innocent and pathological
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says that a draft guidance on “Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients” should be applicable across other therapeutic areas, as appropriate. In comments on the guidance, PhRMA says it believes that the considerations for inclusion of pediatric patients in
Devices
Akin Gump attorneys say several recent FDA actions indicate a change in the agency’s enforcement discretion policy for laboratory-developed tests (LDTs). Writing in an online post, the attorneys say the agency recently issued a Warning Letter to a laboratory advising it to seek marketing authorization for its genetic
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Petra Hygienic Systems Ontario, Canada (5/7): FDA inspected the firm 12/2018 and cited significant GMP violations for finished pharmaceuticals. For