Devices
An analysis by the Institute for Critical Infrastructure Technology (ICIT) says that the FDA cybersecurity guidelines for medical device manufacturers are following a “subtle suggestion” approach when regulatory enforcement is needed. In a blog white paper, ICIT says that the argument against enforcing cybersecurity standards typically “centers on the idea
Drugs
FDA has approved an expanded indication for AstraZeneca’s Faslodex (fulvestrant), for combination use with palbociclib in treating women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) whose cancer has progressed after endocrine therapy. Single-therapy Faslodex has been
Drugs
Sen. Susan Collins (R-ME) has introduced the Increasing Competition in Pharmaceuticals Act (S. 2615) to increase generic drug competition by improving the review and approval of ANDAs and establishing a clear timeline for FDA to expedite review of certain applications for generic drugs. Sections in the bill say their
Drugs
Researchers from the Perelman School of Medicine at the University of Pennsylvania say social media like Twitter could become a useful tool for clinical researchers’ recruitment efforts, but there are caveats. Challenges include “noncoercive content and the assurance of privacy, both of which the IRBs [institutional review boards] will need
FDA Policy/General
Republican presidential candidate Donald Trump has outlined his healthcare reform plan that calls for “allowing consumers access to imported, safe and dependable drugs from overseas” to give more options to consumers. His plan would remove barriers to entry into free markets for drug providers that offer safe, reliable and cheaper
FDA Policy/General
Senate Democrats on the HELP Committee have introduced the National Biomedical Research Act to increase funding for targeted biomedical initiatives through a new, reliable funding stream supporting FDA and the National Institutes of Health (NIH). A statement issued by the senators (contains link to bill text) says that the NIH
Drugs
FDA has issued Teva a complete response letter on its epinephrine ANDA, a generic copy of Mylan’s EpiPen, indicated for emergency treatment of allergic reactions, including potentially fatal anaphylaxis. Teva says the agency cited “certain major deficiencies,” and it intends to submit a response. The company says it expects
FDA Policy/General
A new Ironwod Pharmaceuticals ad campaign for Linzess (linaclotide), indicated to treat irritable bowel syndrome (IBS) with constipation, is intended to ease patients’ discomfort in discussing symptoms like abdominal pain. The Boston Globe reports that ads will appear on network and cable television, the Internet, and in print and are
Devices
MedTech Review senior consultant John Beasley says that while there is a three-year transition period for the third edition of the international quality standard for medical manufacturing, ISO 13483:2016, which was published 2/24, medical device manufacturers and their suppliers would be wise to start their transition planning
FDA Policy/General
Federal Register Notice: FDA seeks comments on research entitled “Animation in Direct-to-Consumer Advertising.” This study will examine how animation affects the comprehension of direct-to-consumer television advertisements for prescription drugs. Comments should be submitted by 5/2. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA’s collection of information entitled “Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting.” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA’s collection of information entitled “Electronic User Fee Payment Request Forms” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA seeks comments on the collection of information, “Reporting Associated With New Animal Drug Applications (NADA) — 21 CFR 514.1, 514.4, 514.5, 514.6, 514.8, 514.11, 558.5.” Comments should be submitted by 5/2. To view this notice, click here.
Drugs
Attorney Jeffrey Gibbs (Hyman, Phelps & McNamara) says that how a therapeutic product is classified profoundly affects how it is regulated, and it is time to reform the FDA mechanism for classifying products. Writing in an online FDLI Update, Gibbs says that the two primary problems with the current system
Devices
Attorney Michelle Yeary says that medical device suits that survive preemption challenges often have difficulty proceeding due to stringent requirements placed on them. Writing online in a Drug and Device Law Blog post, Yeary cites Swisher v. Stryker Corp in which a plaintiff claiming injury from a hip implant asserted
Drugs
The Government Accountability Office (GAO) says it is too early to determine whether the FDA pediatric voucher program has stimulated development of drugs to treat or prevent rare pediatric diseases. Since drug development time often takes a decade, the GAO report says, insufficient time has elapsed to determine whether the
Devices
FDA has cleared a Philips Respironics 510(k) for the Care Orchestrator, a cloud-based clinical management software application for home use that “connects the portfolio of sleep and respiratory care enabling data, clinical management workflow, informatics and intelligence for providers, payers and patients within a single platform,” according to
Devices
Roche has submitted a 510(k) for the cobas c 513 analyzer as a dedicated, high-throughput HbA1c testing solution for people with diabetes. The submission is intended to address the growing prevalence and incidence of diabetes, with projections of 39 million people in the U.S. affected by the
Devices
AdvaMed has submitted its suggested priorities for CDRH’s FY 2016 proposed guidance development. The trade group also submitted recommendations for guidance documents it believes should be part of the Center’s 2016 plans, but are not, along with recommendations on guidances to be updated or withdrawn. For proposed guidances
Drugs
There has been a growing use of animation in prescription drug direct-to-consumer (DTC) advertising and promotional activities, and now FDA has decided to study whether such use minimizes risk or inflates efficacy perceptions. A just-posted agency notice seeks comments on the proposed research that is intended to
Drugs
FDA has given Edwards Lifesciences expanded approval for its Sapien XT transcatheter heart valve for pulmonic valve replacement procedures. The approval covers treating adult and pediatric patients who suffer from either a narrowed pulmonary valve or moderate or greater pulmonary regurgitation caused by congenital heart disease. Expanded approval was supported
Devices
FDA says that Argo Medical Technologies has not complied with an agency 6/26/16 order to conduct post-market surveillance (PS) of its ReWalk medical device. A just-released 9/30/15 Warning Letter says the order was issued because the device’s failure to prevent a fall would