Devices
FDA has cleared a DynoSense 510(k) for its Vital Signs Measuring System, a cloud-based measuring and recording platform. The device captures electrocardiogram, respiration rate, oral body temperature, functional oxygen saturation of arterial hemoglobin, optical photoplethysmogram for pulse rate, and heart rate data. The company says it wirelessly communicates
Drugs
FDA has issued a final guidance, Child-Resistant Packaging Statements in Drug Product Labeling, to assist applicants, manufacturers, packagers, and distributors who choose to include child-resistant packaging statements in their drug product labeling. The document discusses what information should be included to support child-resistant packaging statements in labeling
Drugs
Attorney Kellie Combs (Ropes & Gray) says that while FDA wants to work with industry on incorporating elements of real-world evidence (RWE) in drug development programs, many in industry have said it’s not likely that industry will start to conduct a lot of RWE studies until there is
Devices
FDA has cleared a SpineWelding 510(k) for its Elaris Pedicle Screw System, which is intended to provide immobilization and stabilization of spinal segments through posterior, non-cervical, pedicle fixation in skeletally mature patients as an adjunct to fusion. The device is indicated for use in treating degenerative disc disease,
Drugs
A group of U.S. Senate Democrats is urging FDA acting commissioner Ned Sharpless to heavily punish AveXis for submitting “manipulated” data (see story) with recently approved Zlogensma, a gene therapy product intended to treat children less than two years old with spinal muscular atrophy. The agency says it was
Devices
FDA has cleared a Shimadzu Medical Systems 510(k) for the Fluorospeed X1 patient side conventional radiographic/fluoroscopic (RF) table system. The device offers high image bariatric and routine daily fluoroscopic and radiographic exams, according to the company, including chest, abdomen, or extremities along with upper GI’s, modified swallows
Drugs
Federal Register notice: FDA has extended the comment period on a 7/9 notice about a public meeting entitled “Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs; Public Meeting; Request for Comments.” Comments are now being accepted until 9/16. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced an 11/7 public meeting entitled “Promoting Effective Drug Development Programs: Opportunities and Priorities for FDA’s Office of New Drugs.” The meeting will seek specific, actionable policy suggestions that could be implemented in the near-term by CDER’s review staff to promote
FDA Policy/General
Federal Register notice: FDA has announced an 11/7 public meeting entitled “Promoting Effective Drug Development Programs: Opportunities and Priorities for FDA’s Office of New Drugs.” The meeting will seek specific, actionable policy suggestions that could be implemented in the near-term by CDER’s review staff to promote
FDA Policy/General
FDA has issued a warning against Miracle Mineral Solution (MMS) because it is illegally promoted as a remedy for treating autism, cancer, HIV/AIDS, hepatitis and flu, among other conditions. “However, the solution, when mixed, develops into a dangerous bleach which has caused serious and potentially life-threatening side effects,
Drugs
FDA has granted Dare Bioscience a qualified infectious disease product designation for its novel thermosetting hydrogel-containing clindamycin phosphate 2% and its use for treating bacterial vaginosis in women. The company says its thermosetting hydrogel formulation can result in better antibiotic delivery to the vaginal infection, which can lead to
Devices
Fresenius Kabi has recalled its Volumat MC Agilia Infusion Pumps and Vigilant Agilia Drug Library due to a “low priority — keep vein open, end of infusion” alarm and multiple software errors. “When enabled, the ‘keep vein open, end of infusion’ alarm triggers when the infusion is complete,” a recall notice
FDA Policy/General
Draft Guide on Fabry Disease Drug Development Federal Register notice: FDA makes available a draft guidance on Fabry Disease drug development. 08/08/2019 Info Collection on IVD Study Informed Consent Federal Register notice: FDA sends to OMB an information collection extension for its guidance on informed consent for in
FDA Policy/General
India’s Natco Pharma has signed a licensing agreement with Gilead Sciences, which allows Natco to sell generic versions in 91 developing countries of its hepatitis C treatment Sovaldi (sofosbuvir) and combination therapies using the active ingredient. Pfizer is closing a manufacturing plant in Foothill Ranch, CA that makes vitamins
FDA Policy/General
DEVICES AliveCor has received FDA approval for its AliveECG app, which can run an algorithm that detects atrial fibrillation. The company says the app runs on a smartphone and the patient places their hand over an AliveCor nodule device that fits over the back of the phone. It says the
Devices
FDA has given Endologix the green light to begin a pivotal study to evaluate the safety and effectiveness of its Nellix Chimney EndoVascular Aneurysm Sealing System and its use for the endovascular treatment of complex abdominal aortic aneurysms (AAA). The device combines the company’s Nellix 3.5 endograft with
Drugs
Is biotech G1 Therapeutics, which was cofounded by FDA acting commissioner Ned Sharpless, getting preferential treatment for its cancer drug trilaciclib? Progressive watchdog group Restore Public Trust says something smells fishy after the drug was recently given “breakthrough status” and company officials have reportedly been told by FDA to prepare
Drugs
FDA says it is planning an 11/7 public meeting on “Promoting Effective Drug Development Programs: Opportunities and Priorities for FDA’s Office of New Drugs” to obtain “actionable policy suggestions“ for CDER review staff “regarding opportunities to promote effective drug development while maintaining the FDA’s regulatory standards for
Drugs
FDA has sent Kala Pharmaceuticals a complete response letter (CRL) on its NDA for KPI-121 (loteprednol etabonate) 0.25% for the temporary relief of dry eye disease signs and symptoms. The agency letter recommended efficacy data from an additional clinical trial before resubmission, the company says. Kala says it
Drugs
A new FDA Impact Story discusses new research the agency has undertaken to help would-be generic topical dermatological drug product developers demonstrate bioequivalence. “FDA collaborated with international researchers to evaluate a new method for monitoring the amount of a topical drug in the dermis,” it says. “In a procedure
Drugs
FDA has accepted for review an Ortho Dermatologics NDA for tazarotene 0.045%) lotion for treating moderate to severe acne. The agency has set a 12/22 user fee review action target date. The submission includes data from two Phase 3 trials in 1,614 patients. The primary efficacy endpoints
Drugs
Amarin says it expects FDA will extend its review of a supplemental NDA seeking an expanded indication for Vascepa (icosapent ethyl) capsules based on data from the REDUCE-IT cardiovascular (CV) outcomes study. The current user fee review action target date is 9/28, but FDA told the company 8/