Drugs
Life sciences and healthcare respondents to a Deloitte poll say that supply chain fraud increased to 35% of companies in 2016 from 31% in 2014. Overall, poll respondents from many sectors reported that for the third consecutive year, the level of supply chain fraud remained at about 30%. “From a
Devices
FDA has approved a Medtronic PMA for the Micra Transcatheter Pacing System, the first pacemaker that does not require wired leads to provide an electrical connection between the pulse-generating device and the heart. The self-contained, inch-long device is implanted directly in the right ventricle chamber of the
FDA Policy/General
Federal Register Notice: The FDA commissioner is renewing the Bone, Reproductive and Urologic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 3/23/18. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is amending the notice of a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to reflect a change in date to 5/25 from 8 a.m. to 5 p.m. This meeting was announced in the 3/16 Federal Register and is scheduled to
Devices
FDA has released statistics showing a “slight” decrease in medical device manufacturer inspections in 2015 than in 2014, according to attorney Nathan Reeves (Knobbe Martens). Writing in an online blog post, Reeves says there were 2,104 inspections in 2015, compared with 2,213 in 2014. “Despite the drop of
FDA Policy/General
The Senate Health, Education, Labor and Pensions (HELP) Committee has voted out five bills that completes the Senate’s work on companion legislation to the House’s 21st Century Cures Act that passed last year. What is missing is an agreement on mandatory funding for the National Institutes of Health.
Devices
FDA has cleared an Advanced Brain Monitoring 510(k) for its Sleep Profiler, an overnight sleep monitor and electroencephalogram for patients with insomnia or mood disorders that is intended for diagnosing sleep apnea. “Clinical study results, required for FDA clearance, showed the Sleep Profiler PSG2 delivers unparalleled accuracy in the
FDA Policy/General
Federal Register Notice: FDA is amending a notice of a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee announced in the 3/17 Federal Register. The date of the meeting is changed to from 5/25 to 5/24. The committee will discuss the safety and efficacy of a
Drugs
A 3/9-3/12/15 FDA inspection at the Wellness Pharmacy, Winchester, Virginia, identified multiple violations in the firm’s compounding of sterile drug products. Wellness has informed FDA that it stopped producing compounded sterile drugs as of 3/12/15. A 3/23 Warning Letter from the agency
Drugs
The New England Journal of Medicine, considered by many to be the best known and most venerated such journal in the world, is now the subject of concerns that it is slipping in relevancy and reputation, according to a ProPublica report co-published with the Boston Globe The report discusses
Drugs
FDA says that a 10/6-10/30/15 Bioresearch Monitoring Program inspection of two clinical trials conducted by Dr. Cheta Nand in Richland, WA, determined that Nand “did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations. A just-released 3/10
Drugs
FDA has again changed its mind on the question of whether a biosimilar’s labeling should identify itself as a biosimilar. That’s one of the takeaways attorney James Shehan (Hyman, Phelps & McNamara) sees in the FDA 3/31 guidance on biosimilar labeling. Writing in his firm’s FDA
Drugs
New FDA warnings are being added to Type 2 diabetes medicines containing saxagliptin and alogliptin after an agency safety review found that they may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. The warnings are an extension of a 2014 drug safety
Drugs
Medical students from Harvard and Tufts and members from an activist group staged a “die-in” 4/1 in front of the Tufts Center for the Study of Drug Development (CSDD), claiming a recent study by Tufts associate professor Joseph A. DiMasi is biased. About two dozen protesters demanded that
Drugs
FDA medical reviewers did not raise any serious issues about Intercept Pharmaceuticals’ NDA for obeticholic acid (OCA) for treating primary biliary cirrhosis in combination with ursodeoxycholic acid in adults with an inadequate response to ursodeoxycholic acid or as monotherapy in patients unable to tolerate it. The reviewers’ comments were in
Devices
The Federal Trade Commission (FTC), working in conjunction with FDA and the HHS Office of National Coordinator for Health Information Technology and Office for Civil Rights, has developed a Web-based tool for designers of health-related mobile apps to help developers understand what federal laws and regulations might apply
Biologics
FDA has approved Hospira’s Inflectra (infliximab-dyyb), a biosimilar product referencing Janssen Biotech’s Remicade. This is the second biosimilar approved by the agency since the passage of the Biologics Price Competition and Innovation Act of 2009. The approval covers the following indications: * adult patients and pediatric patients (ages
Drugs
FDA representation is missing from a National Cancer Institute (NCI)-created blue ribbon panel of scientific experts, cancer leaders, and patient advocates that will guide the scientific direction and goals under vice president Joe Biden’s National Cancer Moonshot Initiative. The panel will serve as a working group of the
Drugs
FDA has posted a guidance on “Contents of a Complete Submission for the Evaluation of Proprietary Names” that describes the information it uses to evaluate proposed proprietary names for drugs and biological products. The agency says the document is intended to assist industry when submitting complete submission packages used 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. Chaotic Labz, Line One Nutrition, Inc., m4 Nutrition Companies LLC, NutraClipse, Inc., Swagger Supps, Total Body Nutrition, Xcel Sports Nutrition, LLC (3/31). Misbranded: The firms offer products which
FDA Policy/General
Federal Register Notice: FDA is making available a final guidance entitled Comparability Protocols —Chemistry, Manufacturing, and Controls Information for New Animal Drugs. This document provides recommendations to applicants on preparing and using comparability protocols for postapproval changes in chemistry, manufacturing, and controls (CMC) information. It is intended to provide recommendations
FDA Policy/General
Federal Register Direct final rule: FDA is amending the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA’s IRB regulations. FDA is clarifying that it may require the IRB to withhold approval of new FDA-regulated