Drugs
Eli Lilly and Incyte say they disagree with an FDA complete response letter requesting additional data for their NDA for baricitinib, a once-daily oral medication for treating moderate-to-severe rheumatoid arthritis. The letter indicated that additional clinical data are needed to further characterize safety concerns across treatment arms,
Devices
FDA has cleared an EnsoData 510(k) for EnsoSleep, a software-only medical device used under the supervision of clinicians to analyze physiological signals and automatically score sleep study results. EnsoSleep is intended for use for the diagnostic evaluation by physicians to assess sleep quality and as an aid in
Drugs
An Epstein Becker & Green client alert predicts an “imminent confirmation” of Scott Gottlieb to be the next FDA commissioner, which should be a win for industry based on his support of “flexible systemic approaches to shorten review timelines and bring more products to market.” Gottleib’s stance fares well
Devices
FDA has cleared an Advanced Cooling Therapy 510(k) for use of its Esophageal Cooling Device (ECD) with the Altrix Precision Temperature Management System by Stryker. The ECD is designed to modulate and control patient temperature when clinically indicated through a single use, fully-enclosed triple lumen system that is
FDA Policy/General
The former CEO of Action Packing and Design, Paul Rodriguez, has pleaded guilty to trafficking in counterfeit labels and packaging, according to southern Texas acting U.S. Attorney Abe Martinez. Between 7/2015 and 12/2016, “Rodriguez intentionally trafficked in counterfeit labels and packaging by manufacturing, and then shipping to
Drugs
Attorneys Rachel Hunt and JP Ellison (Hyman, Phelps & McNamara) cite a Pennsylvania federal court decision as further proof that courts have been narrowing situations in which they will find liability under the False Claims Act (FCA) due to a Supreme Court decision in United Health Services v. United States
Devices
FDA has cleared an Additive Orthopedics 510(k) for its 3D printed Locking Lattice Plating System and its use to address stabilization and fusion of fractures, osteotomies, and arthrodesis of small bones. “These plates can be implanted either alone with locking or non-locking screws, or in conjunction with our
Devices
FDA has cleared an Entellus Medical 510(k) for the XprESS ENT Dilation System and its use in patients with persistent Eustachian tube dysfunction. The clearance is based on data from a trial in 60 patients who were randomized to either Eustachian tube dilation using XprESS or a control using
Drugs
Staffers in the CDER Office of Hematology and Oncology Products say that of more than 250 new drug and biologic applications approved by the office since 2006, only one was approved for use with radiation. Writing in an International Journal of Radiation Oncology commentary (subscription or purchase required), the staffers
Devices
Attorney Kate Stewart (Mintz Levin) says the FBI recently issued guidance specifically applicable to medical and dental facilities about the cybersecurity risk of File Transfer Protocol (FTP) servers operating in “anonymous” mode. Writing in an online blog post, Stewart says FTPs are routinely used to transfer information between network hosts.
FDA Policy/General
Federal Register notice: FDA has extended the comment period for the draft guidance for industry #187 “Regulation of Intentionally Altered Genomic DNA in Animals” that was announced in the 1/19 Federal Register. The extension was made in response to requests for additional time to submit comments. Electronic or written
FDA Policy/General
Federal Register notice: FDA has identified 71 Class 1 devices that are now exempt from premarket notification requirements, subject to certain limitations. The agency believes that the device types are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety
Drugs
FDA has determined that Amgen’s erythropoiesis-stimulating agents (ESAs) epoetin alfa (Procrit and Epogen) and darbepoetin alfa (Aranesp) no longer require a Risk Evaluation and Mitigation Strategy (REMS). The REMS, which was limited to the use of Epogen/Procrit and Aranesp to treat patients with anemia due to associated
Devices
A 2/7-17 FDA inspection at Abbott’s St. Jude Medical manufacturing facility in Sylmar, CA, found Quality System Regulation violations in the firm’s manufacturing of the Fortify, Unity, and Assura (including Quadra) implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators and the Merlin@home monitor, according to
Drugs
Purdue Pharma has resubmitted its 3/27 petition asking FDA to place specific restrictions on follow-on products citing its Butrans (buprenorphine) transdermal system for transdermal administration as the reference-listed drug. The company says the requirements are necessary to ensure that any follow-on products are as safe and
Devices
The Campaign for Mercury Free Dentistry is asking FDA to stop amalgam use in children under age 15, pregnant women, and breastfeeding mothers. The petition says that the European Union recently took that action effective 7/1/18. But “the U.S. government has done nothing to protect these vulnerable
Drugs
President Trump has lifted his January-ordered hiring freeze (see earlier story) affecting FDA and other agencies, and instead he has ordered agencies to take immediate actions to reduce staff and cut costs in line with his recent fiscal year (FY) 2018 Budget Blueprint. An Office of Management and Budget
Drugs
FDA has approved a Neurocrine Biosciences NDA for Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia, a neurological disorder characterized by repetitive involuntary movements of the jaw, lips and tongue. The disorder is a serious side effect associated with patients who have been treated with antipsychotic medications, especially the
Drugs
The World Health Organization (WHO) says it is working with finished pharmaceutical product manufacturers to identify additional sources for levonorgestrel following an FDA 3/8 import alert on Qinhuangdao Zizhu Pharmaceutical in Hebei, China. In its response to the import alert, WHO says that FDA investigators found failures in the
Drugs
Attorney Anne Walsh (Hyman, Phelps & McNamara) says the Department of Justice (DoJ) enforced FDA current good manufacturing practice (cGMP) regulations through a 1/12 False Claims Act (FCA) global settlement with Baxter Healthcare. In a Washington Legal Foundation Counsel’s Advisory, she raises the question of whether it is
Devices
FDA has cleared a Ventec Life Systems 510(k) for VOCSN, a portable life support device that combines five respiratory therapies — ventilation, oxygen, cough, suction, and nebulization. Ventec says the device is designed to work across the continuum of care, from the hospital to home, for pediatric patients weighing more
Devices
FDA has cleared a United Orthopedic 510(k) for its E-XPE polyethylene knee insert that is designed to provide patients with knee replacements with reduced risk of oxidation. The device is made of “highly cross-linked polyethylene blended with 0.1 percent (w/w) vitamin E to enhance wear