Drugs
Alcon has withdrawn from the market its CyPass Micro-Stent for surgical glaucoma due to safety concerns documented in a five-year study. The COMPASS-XT study showed that at five years, the CyPass Micro-Stent group experienced statistically significant endothelial cell loss compared to the group who underwent cataract
Drugs
Pfizer has petitioned FDA to tighten bioequivalence requirements for any ANDA submitter seeking to gain approval for generic copies of its Premarin (conjugated estrogens) tablets. The petition seeks to revise a 12/2014 draft guidance on methods for establishing active pharmaceutical ingredient sameness and bioequivalence for conjugated estrogens. Pfizer had
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new proposed information collection entitled “Generic Clearance for Quantitative Testing for the Development of FDA Communications.” The information collection would allow FDA to use quantitative social/behavioral science data collection techniques (i.e., surveys and experimental studies) to test consumers’ reactions
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Medical Device Labeling Regulations — 21 CFR Parts 800, 801, and 809” (OMB Control Number 0910-0485). The information collection supports FDA’s regulations that establish requirements for the label or labeling of a medical device so that
Drugs
FDA has issued a safety warning following a Camber Pharmaceuticals recall of one lot of montelukast sodium tablets. Sealed bottles labeled as montelukast were found to instead contain losartan potassium tablets, 50 mg. “This tablet mix-up may pose a safety risk as taking losartan tablets when not prescribed has
Devices
Compass Health Brands has recalled its continuous positive airway pressure (CPAP) mask cushion seals due to possible air leaks. The replacement seals are used with the firm’s Probasics Brand Zzz-Mask SG Full Face CPAP Mask and had a design change that causes them to be incompatible with the
Devices
FDA has cleared a Quidel 510(k) for its Sofia 2 Lyme Fluorescent Immunoassay and its use with the Sofia 2 Fluorescent Immunoassay Analyzer for rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from finger-stick whole blood specimens to aid in Lyme disease diagnoses. “Sofia
Drugs
FDA has issued Sunovion Pharmaceuticals a complete response letter rejecting its NDA for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor for treating attention-deficit hyperactivity disorder. The letter asked for additional clinical data to further evaluate the drug’s efficacy and tolerability, according to the company. Sunovion
Drugs
FDA has approved Bayer’s Jivi (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older. The agency also approved Jivi for on-demand treatment and perioperative management of bleeding in the same
FDA Policy/General
Federal Register notice: FDA has announced a pilot meeting program to allow sponsors to discuss the use of complex innovative trial design (CID) approaches in medical product development. Meetings under the pilot program will be conducted by CDER or CBER. For each sponsor whose meeting request is granted, the agency
Drugs
FDA has granted Insys Therapeutics a fast track designation for its epinephrine nasal spray as an investigational treatment for anaphylaxis. “In a previous clinical trial, the intranasal epinephrine product candidate from Insys showed promise as a potential needle-free, non-invasive and easy-to-use alternative to intramuscular injection for
Drugs
The National Association of Chain Drug Stores says it is concerned that FDA draft guidances on waivers of the single, shared system (SSS) risk evaluation and mitigation strategy (REMS) requirement and on development of a shared system risk evaluation and mitigation strategy would not stop brand drug manufacturers from manipulating
Drugs
CDER statistical researchers say they are promoting and developing innovative clinical trial designs to meet the challenges of precision medicine. In an online research post, the statisticians describe work they undertook a few years ago during the Ebola outbreak to evaluate new treatments for the deadly viral disease. They then
Drugs
FDA is modernizing its overall approach to regulation to effectively advance the kinds of medical innovations that are becoming available, according to FDA commissioner Scott Gottlieb. In a lengthy FDA Voice blog post, Gottlieb says the changes, including modernizing organization of the medical product review programs, are part of the
Drugs
The New Jersey federal court has entered an order of permanent injunction against several firms and their executives charged with selling unapproved and misbranded drugs to U.S. consumers through more than 100 Web sites. According to an FDA statement, the defendants’ products claimed, without FDA approval or clinical studies
Drugs
FDA has approved Auris Medical’s proposed choice of primary and secondary efficacy endpoints, the safety endpoints, as well as the planned sample size and statistical methodology for a pivotal Phase 3 trial of AM-111 (brimapitide), an investigational treatment for sudden sensorineural hearing loss. In a recent meeting with
Drugs
FDA has approved two Merck NDAs for human immunodeficiency virus (HIV)-1 drugs — Delstrigo, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (300 mg) and tenofovir disoproxil fumarate (300 mg); and Pifeltro (doravirine) 100 mg, a new non-nucleoside reverse transcriptase inhibitor to be administered in
Drugs
A bipartisan group of three House members have introduced H.R. 6688 to establish the Prescription Safety Alert System for covered drug products. The legislation, introduced by Reps. Tom Macarthur (R-NJ), Ann Kuster (D-NH), and Barbara Comstock (R-VA), is known as the Analyzing and Leveraging Existing Rx
Devices
University of California, San Francisco, School of Medicine researchers say that to best ensure safety and effectiveness of high-risk medical devices, FDA should require high quality data under its new breakthrough devices program designation. In a JAMA Internal Medicine Research Letter, they also call on the agency to ensure
Drugs
FDA has accepted an Ultragenyx Pharmaceutical proposal to submit an NDA for UX007 for treating long-chain fatty acid oxidation disorders based on existing data. A pre-NDA meeting is being scheduled for later this year to iron out the submission details, the company says. Data submitted to FDA for
FDA Policy/General
Federal Register notice: FDA has reopened for 14 days the comment period on its draft guidance entitled “Development of a Shared System Risk Evaluation and Mitigation Strategy.” To view the notice, click here.
Drugs
FDA commissioner Scott Gottlieb says the agency plans to withdraw its 2014 analgesic guidance document on developing new pain drugs and replace with at least four new guidances to create a more efficient path for new product innovation. In a statement updating progress against the opioid epidemic, Gottlieb says the