Biologics
Ortho Clinical Diagnostics has recalled RhoGAM Ultra-filtered PLUS [rho (d) immune globulin (human)] due to a shipping error which resulted in packaging with non-English labeling. A recall notice says use of this product may result in an administration error or use where contraindicated because the label and package
Biologics
FDA has accepted for review a Merck BLA for bezlotoxumab, an investigational antitoxin for preventing Clostridium difficile (C. difficile) infection recurrence. The agency has granted a priority review, with a user fee review target date of 7/23. The submission based in part on data from the pivotal MODIFY I
Devices
FDA has classified as Class 1 a Thornhill Research revised recall of its Moves Ventilator System because excess glue on the battery connectors may prevent it from powering the device after the battery is stored. The defect may prevent the ventilator from providing patient breathing support and could cause patient
Drugs
Sen. Bernie Sanders (I-VT) has placed a hold on FDA commissioner-nominee Robert Califf’s confirmation because of his close ties to the pharmaceutical industry and lack of commitment to lowering drug prices. Sanders’ hold comes on the heels of a separate hold placed by Sen. Edward J. Markey
Drugs
AIDS Healthcare Foundation (AHF) filed a federal lawsuit 1/26 against Gilead Sciences seeking to invalidate patents on key AIDS drugs held by the drug maker. The complaint was filed in Northern District of California (Case # 3:16-cv-00443) and concerns tenofovir, a key HIV/AIDS drug which was
Drugs
FDA said 12/17/15 that it will participate in the operational phase of the Medical Device Single Audit Program (MDSAP) starting 1/1/17. It currently is part of the MDSAP pilot that runs for the rest of this year. Attorneys John Wyand and Sarah Stec (Squire Patton Boggs)
Drugs
After a 24-year career at FDA, CDRH associate director for international affairs Kim Trautman has retired and joined consulting group NSF International Medical Devices as executive vice president of international regulatory compliance services. Trautman is described as an expert in medical device quality systems and international regulatory affairs. At
Biologics
FDA has accepted for review an Amgen BLA for ABP 501, a biosimilar candidate referencing AbbVie’s Humira (adalimumab), indicated for treating chronic inflammatory conditions, such as rheumatoid arthritis, plaque psoriasis and Crohn’s disease. The submission is based on analytical, clinical and pharmacokinetic data, according to Amgen. It says
FDA Policy/General
Federal Register Notice: FDA is providing an opportunity interested persons to submit written comments and to request an informal public meeting on recommendations by the World Health Organization to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The five drug substances involved are: acetylfentanyl, MT-
FDA Policy/General
Federal Register Notice: FDA Cincinnati District, in co-sponsorship with Xavier University will hold a public conference entitled “FDA/Xavier University PharmaLink Conference: Increasing Product Confidence.” The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of FDA, featuring presentations from key FDA officials,
FDA Policy/General
Federal Register Notice: FDA is requesting that industry organizations interested in participating in selecting nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) for CDRH notify FDA in writing. The agency is also requesting nominations for nonvoting industry representatives to serve on the NMQAAC. To
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Green Supreme, Inc. West Middlesex, PA (1/15). Reviewed Web site at www.greensupreme.net 11/2015. Misbranded: The claims on the Web site establish that the products are
Devices
A five-month inspection at Invacare, Elyria, OH, found that the company is not living up to terms of a consent decree for its wheelchair manufacturing operations signed with FDA in 2013, a Crain’s Cleveland Business report says. An FDA-483 listed the inspection period as 7/16/15
Biologics
South Korea-based Green Cross Corp. has filed a BLA for IVIG-SN (human normal immunoglobulin G for intravenous administration), indicated for treating primary immunodeficiency diseases (PID). The company expects a user fee review target in the fourth quarter. The submission is based on Phase 3 data that demonstrated positive
Devices
Former FDA special assistant to the associate commissioner for regulatory affairs Martin Browning, now president of EduQuest, says that an inspected company’s response to an FDA-483 observation “is your last and best opportunity to tell your side of the story before higher-ups in the agency (including enforcement
Devices
An 8/31-9/1/15 FDA inspection at LAR MFG, Port Richey, FL, found Quality System Regulation violations in the firm’s manufacturing of ceramic dental brackets, according to a just-released 12/9/15 Warning Letter from the agency’s Florida District Office. Specific violations noted on an
Drugs
With clinical trial patient recruitment continuing to face significant challenges, drug developers are focusing on improving patient recruitment and retention practices, according to a roundtable discussion of drug company senior managers and industry consultants convened by the Tufts Center for the Study of Drug Development. Results of that discussion are
FDA Policy/General
Four Armstrong Teasdale attorneys say that three federal agencies, including FDA, are likely to increase their oversight of social media ads in 2016. Writing in an online blog post, the four say recent statements and actions by FDA, the Federal Trade Commission (FTC), and the Consumer Financial Protection Bureau (CFPB)
FDA Policy/General
Federal Register Notice: FDA has determined that Izba (travoprost ophthalmic solution), 0.003 %, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve ANDAs for travoprost ophthalmic solution/drops, 0.003 %, if all other legal and regulatory requirements are met. To view
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices. The agency aims to assist industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange and use
Drugs
Shire has resubmitted an NDA for lifitegrast for treating signs and symptoms of dry eye disease. The submission includes data from a recent study called OPUS-3, a Phase 3 efficacy and safety study of lifitegrast versus placebo. The data, according to the company, showed OPUS-3 met the primary
FDA Policy/General
Senator Edward Markey (D-MA) has placed a hold on FDA commissioner nominee Robert Califf’s Senate confirmation, calling for immediate reforms to the agency’s approval process for opioid painkillers. “Specifically, Senator Markey is calling for the FDA’s commitment to convene advisory committees for any future opioid-approval