Drugs
FDA has cleared an Exact Imaging 510(k) for its ExactVu micro-ultrasound system for urological procedures. The device provides a resolution down to 70 microns, which is a 300% improvement in imaging resolution compared to traditional standard-of-care urological ultrasound systems, according to the company. Urologists now have
Drugs
The Association of Clinical Research Organizations (ACRO) says it welcomes and supports creation of an International Conference on Harmonization guideline on multi-regional clinical trials (MRCTs). “ACRO’s view is that the draft guideline represents a very well-considered approach to the issues raised by MRCTs and is an excellent
Biologics
The U.S. acting solicitor general is recommending that the Supreme Court hear appeals by Amgen and Sandoz on the implementation of portions of the Biologics Price Competition and Innovation Act (BPCIA). In an amicus brief, the acting solicitor general says that a Federal Circuit Court of Appeals conclusion that
Drugs
FDA associate commissioner for global regulatory policy Dana Corrigan says a Mutual Reliance Initiative (MRI) with the European Union (EU) allows FDA and EU inspectors to work together, relying on each other’s inspections, avoiding duplication, and conducting more inspections. Writing in an FDA Voice blog post, Corrigan says the
Drugs
Pharmaceutical Research and Manufacturers of America says the reauthorization of the Biosimilar User Fee Act for FY 2018-2022 (BsUFA 2) “provides the resources and support needed for FDA to achieve its core mission of protecting and promoting public health.” The association says the reauthorization agreement will continue to build
Devices
FDA says it will no longer require medical evaluations and signed waivers before consumers purchase a hearing aid. In addition, the agency is considering creating a special over-the-counter (OTC) category for certain hearing aids that will likely lower costs for consumers. “Today’s actions are an example of
FDA Policy/General
Federal Register Notice: FDA has made available data extracted from adverse event reports from 2004 to the present for food (including food additives, color additives, and dietary supplements) and cosmetics regulated by CFSAN. The data files are being made publicly available on the agency’s Web site to improve transparency
Drugs
President-elect Donald Trump may want to shake FDA up and reform its outdated approval programs, and maybe that is why his transition team reportedly is considering a Silicon Valley investor close to billionaire Peter Thiel to lead the agency. Jim O’Neil, a managing director of one of Theil’
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Merck’s Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) for patent extension purposes is 2,662 days. Of this time, 2,296 days occurred during the testing phase, while 366 days occurred during the approval phase. To view
Drugs
An FDA inspection at the Sun Pharmaceutical facility in Halol, India, resulted in a 14-page FDA-483 list of observations, Bloomberg News reports. A Mumbai securities analyst told the news service that the length of the report gives it a negative connotation. “We don’t know if it will
Devices
Medtronic says it is partnering with Fitbit to integrate health and activity tracking for patients with diabetes and their doctors and care teams. The companies say they are working on a mobile app to allow patients with Type 2 diabetes to see their glucose levels and physical activity data in
Devices
FDA has granted Voluntis 510(k) clearance for Insulia, a digital solution intended to support the effective management of Type 2 adult diabetes patients treated with basal insulin. According to the company, the prescription-only medical device provides patients with insulin dose recommendations and educational coaching messages in response to
Drugs
Kitov Pharmaceuticals Holdings says it has completed FDA-required stability testing on nine pivotal batches of KIT-302, three in each dosage form (celecoxib/amlodipine of 200 mg/10 mg, 200 mg/5 mg, and 200 mg/2.5 mg). The testing met the criteria demonstrating stability for six months,
FDA Policy/General
One week after the House passed the 21st Century Cures Act, the Senate has voted 94 to 5 to pass the bill, and it now heads to president Obama’s desk for signing. After the vote, Senate Health, Education, Labor and Pensions committee chair Lamar Alexander (R-TN) called the
Drugs
A former FDA official is calling out the agency over a couple of recent approvals that he says defy common sense and lack scientific proof that they are safe and effective. Writing in a Stat News opinion piece, former FDA medical officer and now Georgetown University pharmacology professor David Gortler
Devices
In a paper prepared for the Annual Computer Security Applications Conference, researchers say there are “serious protocol and implementation weaknesses on widely used implantable cardioverter defibrillators (ICDs) which lead to several active and passive software and radio-based attacks that we were able to perform in our laboratory.” The article
Drugs
A 5/2-5/6 FDA inspection at Interquim, Barcelona, Spain, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API), according to an 11/22 Warning Letter. Specific deviations included: * failing to have adequate cleaning procedures that define and justify acceptance criteria for residues; * failing to
Drugs
As the Senate prepares for a floor vote Wednesday (12/7) on the 21st Century Cures Act, Senate Judiciary Committee members led by ranking member Patrick Leahy (D-VT) have introduced a bipartisan amendment to prevent pharmaceutical companies blocking cheaper generic alternatives from entering the marketplace. The Creating and Restoring
Drugs
The 1st Circuit Court of Appeals has upheld a district court decision allowing a 2012 payment of $700 million from AstraZeneca to Ranbaxy for abandoning its challenge to patents covering Nexium, delaying market entry of a generic Nexium. Attorneys Eric Furman and Caleb Bates (Knobbe Martens Olson & Bear) say
FDA Policy/General
CDER deputy director for regulatory programs Douglas Throckmorton says that FDA’s work to improve the safe use of opioids is “taking place within a larger policy framework aimed at addressing opioid abuse while supporting appropriate access to pain treatment. In an update on the agency’s opioid action plan,
Drugs
CDER Office of New Drugs associate director for therapeutic biologics Leah Christl says that her agency and other major regulators are working toward attaining scientific alignment on biosimilar regulation rather than harmonization. Speaking at the 2016 DIA biosimilars conference, Christl said FDA “avoids using the word harmonization, because harmonization often
Drugs
The only letter relevant to our readership can be accessed by clicking on the link below. Interquim Barcelona, Spain (11/22): FDA inspected the firm’s manufacturing facility in May and cited significant GMP deviations involving its active pharmaceutical ingredients (APIs). For example, the firm failed to have adequate cleaning