Devices
Arkray Factory has begun a Class 1 recall of its SpotChem II Test Strips due to inaccurate blood sugar readings. The reagent test stripa are used to glucose levels in blood samples, and are used with the SpotChem EZ analyzer. A recall notice says the strips are falsely showing low
Drugs
The White House has established a Cancer Moonshot Task Force to be led by vice president Joe Biden, with representatives from 13 government agencies, including FDA, National Institutes of Health and National Cancer Institute. President Obama pledged a moonshot-type effort to cure cancer during his State of the Union
Drugs
Washington Legal Foundation (WLF) says that recent federal appeals court decisions suggest that the Supreme Court’s 2011 decision in Sorrell v. IMS Health has led to an expansion of commercial speech. A WLF online Legal Pulse says that the high court held in Sorrell that content- or speaker-based
Drugs
FDA should not have much say in drug pricing issues, such as expediting new applications for a competing product once a pricing spike has occurred in the marketplace, according to CDER director Janet Woodcock. Testifying at a Senate Health, Education, Labor and Pensions Committee hearing on the generic drug user
FDA Policy/General
As FDA commissioner nominee Robert Califf moves closer to a full Senate confirmation vote, another lawmaker has announced opposition to the appointment. This time it is Sen. Joe Manchin (D-WV), who says he will filibuster Califf’s nomination because of his strong ties to the pharmaceutical industry. Manchin says
FDA Policy/General
Federal Register Notice: FDA seeks public comments on the procedure by which an applicant may obtain an assignment or designation determination for combination products. Comments should be submitted by 3/28. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available additional draft and revised draft product-specific bioequivalence (BE) recommendations for 31 products. The recommendations provide product-specific guidance on the design of BE studies to support ANDAs. The products include recommendations for alprostadil, betamethasone dipropionate, ciclesonide, and elvitegravir. To view this notice,
FDA Policy/General
Federal Register Notice: FDA is making available a revised draft guidance for industry on lamotrigine extended-release tablets entitled Draft Guidance on Lamotrigine. The recommendations provide specific guidance on the design of bioequivalence studies to support ANDAs for lamotrigine extended-release tablets. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA’s Cincinnati District and Xavier University will co-sponsor a public conference 5/4-6 entitled “FDA/Xavier Medical Device Conference (MedCon).” It includes presentations from key FDA officials and industry experts with small group break-out sessions. It will be held 5/4 and 5/
Drugs
The Pennsylvania Medical Society (PMS) is asking FDA to support research leading to development of treatment options with medical marijuana. In a letter to FDA acting commissioner Stephen Ostroff, the society also urges the agency to reschedule marijuana from a Schedule 1 to a Schedule 2 substance to facilitate research
Drugs
Attorney John Bentivoglio (Skadden Arps) says that corporate integrity agreements (CIAs) are “important to those operating under their obligations and to others in the same healthcare sector. They provide important guidance as to what the OIG believes to be effective oversight and operational controls for healthcare organizations. Companies should review
Drugs
FDA has approved Eisai’s Halaven (eribulin mesylate) for treating unresectable or metastatic liposarcoma in patients who received prior chemotherapy containing an anthracycline drug. An agency news release says the drug’s safety and efficacy were evaluated in 143 clinical trial participants with advanced liposarcoma that was unresectable or had
Devices
Colorado Therapeutics has submitted a 510(k) for its xenogenic biologic tissue matrix, intended for use in reinforcing soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes, including hernia defects. The company says the product has been developed in a dry state
Drugs
An FDA-483 details violations found by FDA inspectors at the Wockhardt Shandra plant in western India, according to a Reuters report from Mumbai. The news account says that the 1/12 inspection report said that the results of 22 failed tests had not been recorded and that multiple data
Devices
Issues that did not receive full discussion due to time constraints at a 12/15/15 MDUFA $ reauthorization meeting included 510(k) total time to decision reduction, third-party 510(k) review, digital health, leveraging standards, device-specific guidance, PMA process enhancements and total product life cycle, access to review
Drugs
FDA has approved a Takeda Pharmaceuticals NDA for Dexilant SoluTab (dexlansoprazole) delayed-release orally disintegrating tablets, a new formulation of the drug that can be taken by allowing the tablet to melt in a patient’s mouth. Dexilant SoluTab is a proton pump inhibitor indicated for treating heartburn associated with
Devices
FDA has cleared a Velano Vascular 510(k) for a modified version of its Velano needle-free blood draw device. The device clearance, according to the company, covers two modifications designed to enhance the product’s usability for inpatient blood draws — the addition of a clamp for use with syringe
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “PHS Guideline on Infectious Disease Issues in Xenotransplantation,” has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
Devices
FDA has cleared a PuraCath Medical 510(k) for the FireFly Peritoneal Dialysis Connector Disinfecting System, intended for use by peritoneal dialysis (PD) patients as a method of controlling air and touch contamination while performing solution exchanges. The clearance was supported by in vitro testing that the company says demonstrated
Drugs
In a product liability case brought by a minor who had sought medical treatment for acne, received a prescription for Medicis Pharmaceuticals’ Solodyn, took two 20-week courses of the drug as prescribed by her doctor, and developed drug-induced hepatitis and lupus, the Arizona Supreme Court adopted for the
Drugs
The PDUFA 6 reauthorization post-market subgroup discussed three safety communication issues at its 11/18/15 meeting to determine whether they should be part of negotiations related to PDUFA-funded drug safety activities. Meeting minutes identify the three issues as tracked safety issues, 921 postings, and Sentinel analyses. Agency
Drugs
Researchers looking at the effect of marketing on clinical trials say their work raises questions more than answering them and further study is needed. Writing in the online journal Trials, the researchers say that analysis of trial documentation has indicated that some industry-funded trials may be done more for