FDA Policy/General
Panel to Discuss Chikungunya Vaccine Development Federal Register notice: FDA announces an 11/8 Vaccines and Related Biological Products Advisory Committee meeting to discuss chikungunya vaccine development. 08/23/2019 Correction on Opioids Hearing Federal Register notice correction: FDA corrects a 6/21 notice entitled “Standards for Future Opioid Analgesic
FDA Policy/General
Janssen R&D Ireland has entered into a collaboration with ViiV Healthcare to develop and commercialize a new single tablet regimen containing Janssen’s non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine) and ViiV’s integrase inhibitor Tivicay (dolutegravir) as the sole active ingredients for the maintenance treatment of patients
FDA Policy/General
DEVICES FDA has cleared a CorMatrix Cardiovascular 510(k) for the CorMatrix CanGaroo ECM Envelope for use with cardiac implantable electronic devices including pacemakers and implantable cardioverter defibrillators. The device acts as a pouch to securely hold a cardiac implantable electronic device to create a stable environment when implanted in
Devices
FDA has granted Miracor Medical a breakthrough device designation for its PiCSO Impulse System for treating ST-elevated myocardial infarction patients. PiCSO therapy is intended to be provided by interventional cardiologists during percutaneous coronary intervention in patients experiencing ST-elevated myocardial infarction. It works by clearing the coronary microcirculation by
Devices
FDA has cleared a Drawbridge Health 510(k) for the OneDraw A1C Test System, which comprises the OneDraw Blood Collection Device and the OneDraw A1C Test. The device is intended for collecting and stabilizing blood and measurement of HbA1c levels for monitoring long-term blood sugar control in people with
Drugs
Medline has recalled its Primary Warmer Pack because it contains the recalled Vyaire Medical enFlow Disposable Cartridge, “which may elute aluminum into infused fluids during use, potentially exposing patients to unsafe aluminum levels,” according to a recall notice. “Continued use of these products may result in prolonged, undetected aluminum exposure
FDA Policy/General
Federal Register notice: FDA has announced an 11/8 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss and make recommendations on developing chikungunya vaccines. Chikungunya is an infection caused by the chikungunya virus, which is spread by mosquitos. To view the notice, click here.
Drugs
Former FDA commissioner Robert Califf says the current concern over the inclusion of faulty data in Novartis’ BLA for Zolgensma (onasemnogene abeparvovec-xioi), a novel gene therapy indicated to treat spinal muscular atrophy in children at a cost of $2.1 million for a single, one-time dose, raises questions
FDA Policy/General
FDA principal deputy commissioner Amy Abernathy says the agency “supports the smart, secure, and safe interaction among different medical devices and information systems, and has been collaborating with hospitals, healthcare providers, standards development organizations, and other interested parties to promote medical device interoperability.” Speaking 8/22 at the National Coordinator
Drugs
Altaire Pharmaceuticals has recalled several veterinary ophthalmic drug products due to concerns about quality assurance controls at its manufacturing facility. To date, Altaire says it has not received any adverse event reports associated with the recalled products. According to a recall notice, the products are manufactured and labeled exclusively for
Drugs
An 8/16-8/22 FDA inspection at the Alkem Laboratories drug manufacturing facility at Fenton, MO, resulted in issuance of an FDA-483 with four inspection observations, according to an online Equity Bulls post. The agency also inspected the company’s Baddi, India, manufacturing facility from 8/19 to
Drugs
Attorneys Khelin Aiken and Anisa Mohanty (McDermott Will & Emery) review the FDA proposal to modernize new drug development as authorized by the 21st Century Cures Act. The agency’s 2018 initial proposal, they write in an online post, covered: * focusing on recruiting talent across disciplines; * building multidisciplinary teams for
Drugs
The Bipartisan Policy Center, which includes former FDA commissioners Robert Califf, Andrew von Eschenbach, and Mark McClellan on its leadership team, has issued a report with recommendations for expanding the use of real-world evidence (RWE) in regulatory and value-based payment decision-making for drugs and biologics. In an
Devices
Medline Industries has recalled its Medline Primary Warmer Pack because it contains the recalled Becton Dickinson Alaris Infusion Sets for the Alaris Pump Model 8100. The pump has been associated with faster-than-expected delivery of medication (over-infusion) or an unintended delivery that occurs while the pump is not
Devices
Edwards Lifesciences has recalled its Sapien 3 Ultra Delivery System due to balloon bursts during surgery, which may result in vascular injury, bleeding, or necessary surgical intervention. The device is part of the Sapien 3 Transcatheter Heart Valve System, which is indicated for use in patients with severe, symptomatic, aortic
FDA Policy/General
Federal Register notice correction: FDA is correcting a 6/21 notice entitled “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics To Treat Pain and Addiction; Public Hearing.” That notice was published with incorrect presenter registration and slide deck submission deadlines. To view the notice, click here.
Drugs
Indian drug companies received one-third (13) of the 38 FDA Warning Letters issued as of 8/21, according to an analysis by the print and online environmental publication Down to Earth. U.S. companies received 15 of the letters. “The reason for such high number of Warning Letters to
Devices
CDRH is listing its 10 current regulatory science priorities that “serve as a catalyst to improve the safety, effectiveness, performance, and quality of medical devices and radiation-emitting products, and to facilitate introducing innovative medical devices into the marketplace.” An online list gives the 10 as: * leverage “Big Data” for
Biologics
The Pew Charitable Trusts says that while FDA and members of Congress have taken important steps in recent months to protect consumers from unproven and risky stem cell products offered by hundreds of clinics nationwide, “the agency needs to take broader action to deter businesses from selling interventions whose safety
Drugs
FDA has accepted for priority review a BeiGene NDA for zanubrutinib for treating patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. The submission includes data from a global Phase 1/2 trial (NCT02343120) in patients with B-cell lymphomas and an aggregate of 123
Devices
FDA has cleared a SurGenTec 510(k) for a neurostimulation indication for their Alara Neuro Access Needle Kit. The device is used for targeting and assisting in cannulating a pedicle. Targeting needles are generally the first instrument used to perforate the pedicle wall before advancing a guidewire, tap or pedicle
Drugs
Shilpa Medicare, an active pharmaceutical ingredients (API) manufacturer in Karnataka, India, has been issued a five-observation Form FDA-483 after an inspection concluded 7/26. According to the form, FDA cited Shilpa for failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of