Drugs
FDA has approved a Blue Earth Diagnostics NDA for Axumin, a radioactive diagnostic agent for injection, indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following prior treatment. Approval was based on data from two studies. “The
Drugs
FDA has cleared a Cynosure 510(k) to market a new laser delivery system for its PicoSure aesthetic picosecond laser for removing the full color spectrum of tattoo inks. “The new 1064 nm wavelength is designed for removal of black and other dark tattoo inks,” Cynosure says. The laser is
Devices
FDA has classified as Class 1 a Medtronic recall involving its battery pack used with the Capnostream 20 and Capnostream 20p Patient Monitors due to the potential for thermal runaway that presents a fire risk to the monitor. The pack powers the monitor when AC power is not available or
Drugs
FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted 15 to 1 to recommend approval for a St. Jude Medical PMA for its Amplatzer Patent Foramen Ovale (PFO) Occluder System. The device is indicated for percutaneous, transcatheter closure of a PFO to prevent recurrent ischemic
Biologics
FDA has posted a guidance on “Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components.” The document recognizes standardized full-length and abbreviated donor history questionnaires prepared by the AABB Donor History Task Force as an
FDA Policy/General
DEVICES Comments Extended on Electrical Stimulation Devices Federal Register Proposed rule: FDA is extending the comment period for a 4/25 proposed rule in which the agency requested comments for a ban on electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior. Comments should be submitted by 7/
Drugs
Symbiomix says it had a successful pre-NDA meeting with FDA and has reached agreement with the agency on all aspects for an NDA filing in the fourth quarter of 2016 for its SYM-1219 (secnidazole) for treating bacterial vaginosis. The drug is described as a next-generation, 5-nitroimidazole
Drugs
Researchers at the Massachusetts Institute of Technology are seeking FDA approval for a drug manufacturing plant that is the size of a home refrigerator and can produce 1,000 pills in 24 hours, faster than it takes to produce some batches in a conventional drug manufacturing facility. Kaiser Health News
Devices
FDA officials and industry representatives discussed a comprehensive MDUFA 4 reauthorization package offered by AdvaMed, MDMA, and MITA at their 4/27 reauthorization meeting. Meeting minutes say that the package included potential commitments and proposed resource estimates for several areas, including pre-submissions, quality management, total product life cycle, de
Drugs
FDA has approved a CSL Behring BLA for Afstyla [antihemophilic factor (recombinant), single chain], a factor VIII single-chain therapy for adults and children with hemophilia A. The company says it is the first and only single-chain product for hemophilia A that is specifically designed for long-lasting protection
Drugs
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee has voted 12 to 2 to recommend approval for a Sanofi NDA for iGlarLixi (insulin glargine and lixisenatide) injection and lixisenatide injection as monotherapy, indicated for improving glycemic control in adults with Type 2 diabetes mellitus. Several panel members expressed concern with
Drugs
American College of Rheumatology president Joan Van Feldt and Arthritis Association president Ann Palmer say that FDA should be allowed to do its job and implement transparency measures in biosimilar drug naming and labeling. “It is a common-sense decision that upholds the agency’s responsibility to protect the public
Drugs
FDA has approved a Titan Pharmaceuticals Inc. and Braeburn Pharmaceuticals NDA for Probuphine (buprenorphine), an implant for maintenance treatment of opioid dependence. The product is designed to provide a “constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of
Drugs
FDA says it is requiring safety labeling changes for methadone and buprenorphine products when used by pregnant women for medication-assisted treatment (MAT) of opioid use disorder. The changes are intended to ensure that doctors have complete information on the products’ benefits and risks. An agency notice says that while
Drugs
A shortage of Pfizer’s Bicillin L-A (penicillin G benzathine), the recommended treatment for patients with syphilis and the only treatment available for pregnant women who are infected with or exposed to syphilis, is creating problems according to a National Public Radio report. The company has told consumers that
FDA Policy/General
The Federal Trade Commission will hold a 9/15 workshop to examine the testing and evaluation of disclosures that companies make to consumers about advertising claims, privacy practices, and other information. The “Putting Disclosures to the Test” workshop is focused on encouraging and improving the evaluation and testing of disclosures
Drugs
Members of the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0 on 5/24 to support the safety and efficacy of Novo Nordisk’s Xultophy (insulin degludec and liraglutide injection) for the proposed indication of adjunct to diet and exercise to improve glycemic control in treating adults with
Devices
Halloran Consulting Group principal consultant Michael Wienholt says that the fact that a medical device firm has received ISO 13485 certification does not mean that it is complying with FDA Quality System regulations. “The basic message is that conformity to a standard does not equal compliance with a regulation,” Wienholt
FDA Policy/General
Federal Register Final order: FDA is reclassifying external cardiac compressors (under FDA product code DRM), a preamendments Class 3 device, into Class 2 (special controls). The agency is also creating a separate classification regulation for a subgroup of devices previously included within this classification regulation, to be called cardiopulmonary resuscitation
Drugs
The Supreme Court may decide in June whether to hear Sandoz and/or Amgen’s petitions appealing a Federal Circuit Court of Appeals decision on interpretation of the “notice of commercial marketing” provision of the Biologics Price Competition and Innovation Act (BPCIA). A Big Molecule Watch blog post from Goodwin
Drugs
FDA Office of Chief Counsel (OCC) drugs counselor Julie Dohm has been named CDER senior science advisor for compounding. In this capacity, she will be the agency lead on compounding, developing and managing teams to implement legislation, perform inspections, prepare enforcement actions, develop policy, and conduct outreach to stakeholders. For
Devices
FDA has approved a Roche PMA for its cytomegalovirus (CMV) test for use in hematopoietic stem cell transplant recipients for monitoring CMV treatment. The company says the test was the first in vitro diagnostic test conforming to a WHO International Standard, making it possible for laboratories worldwide to obtain comparable