FDA Policy/General
Federal Register notice: FDA has issued a final rule to remove the specified test for detecting the presence of Mycoplasma for live virus vaccines and inactivated virus vaccines produced from in vitro living cell cultures. The rule is being finalized because the existing test for Mycoplasma is overly restrictive since
Drugs
Amid a swirl of Trumpian controversy, FDA 8/23 issued an emergency use authorization (EUA) for Covid-19 convalescent plasma (CCP) and its use in treating hospitalized Covid-19 patients. Many FDA watchers are calling out FDA commissioner Stephen Hahn for misleadingly stating that 35% of those treated with plasma
Devices
FDA has awarded HelixBind a breakthrough device designation for its RaPID/BSI, a direct-from-blood platform for identifying and characterizing bloodstream infections, such as sepsis. HelixBind says its breakthrough request focused on the features of the RaPID platform that distinguish the test from the current standard of care, such
Drugs
FDA has issued Tricida a complete response letter on its NDA for veverimer, a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease. The letter requested additional data beyond the TRCA-301 and TRCA-301E trials involving the “magnitude and durability of the
Devices
Valencia Technologies has filed a PMA for its eCoin Peripheral Neurostimulator System for use in treating overactive bladder. The device is designed to provide intermittent electrical stimulation of the tibial nerve using a leadless nickel-sized implant. The PMA application that was accepted for filing by FDA was part of
FDA Policy/General
Medeon Biodesign has agreed to sell to Tokyo-based Terumo Corp. its large bore vascular closure system. The transaction includes an up-front payment of $20 million and future milestone payments. The acquired device, a suture-mediated closure device with two braids, is intended to target percutaneous large bore procedures
FDA Policy/General
Federal Register notice: FDA is correcting a notice that appeared in the 7/7 Federal Register that discussed version 1.7 of the Clinical Data Interchange Standards Consortium for Study Data Tabulation Model Implementation Guide 3.3. The document provided the incorrect dates for these electronic study data standards. To
Drugs
CBER director Peter Marks says he would resign if the Trump Administration interfered in an approval decision to speed up access to Covid-19 vaccines. Marks told Reuters that so far he has not felt any political pressure and that the agency will be guided by science alone. Should that
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Dompe Farmaceutici’s Oxervate (cenegermin-bkbj), indicated for treating neurotrophic keratitis. The regulatory review period is 1,484 days, which includes 1,240 days during the testing phase and 244 days during the approval phase.
FDA Policy/General
Federal Register notice: FDA is announcing an 8/28 virtual public meeting entitled “Public Meeting on CDER Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program — Summer 2020.” The meeting will discuss developing standard core sets of clinical outcome assessments (COAs) as part of an FDA pilot grant program,
Devices
FDA has cleared a Pelvital 510(k) for Flyte, an intravaginal home-use device that is intended to strengthen the pelvic floor muscles to help women with stress urinary incontinence (SUI). “Proven in physician-led clinical studies, Flyte leverages the natural healing capabilities of skeletal muscle to provide a time-
Devices
FDA is alerting health care providers (HCPs) that the use of passive protective barrier enclosures (those without negative pressure) when treating Covid-19 patients may pose an increased health risk to patients and other HCPs. The agency says it has become aware of “preliminary evidence in simulated intubation procedure models
Drugs
FDA has cited Living Senior, Las Vegas, NV, over its www.blueribbonhemp.com Web site that markets CBD products for treating Covid-19 patients. An 8/19 Warning Letter took issue with several claims made on the Web site that promote its CBD products for fighting viral infections like Covid-
FDA Policy/General
Federal Register notice: FDA has announced a 10/7 meeting of its Medical Devices Advisory Committee’s Circulatory System Devices Panel, which will discuss a TransMedics PMA for its Organ Care System (OCS) — Heart. The portable ex-vivo organ perfusion and monitoring system is indicated for the resuscitation, preservation, and
Drugs
Bayshore Pharmaceuticals is recalling one lot of metformin hydrochloride extended-release tablets USP, 500 mg, 1,000 count bottles and one lot of 750 mg, 100 count bottles due to the detection of N-nitrosodimethylamine (NDMA) levels above the agency’s acceptable daily intake limit. NDMA is classified as a
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension on “Focus Groups as Used by the Food and Drug Administration (All FDA-Regulated Products).” FDA conducts focus group interviews on many topics involving FDA-regulated products, including drugs, biologics, devices, food, tobacco, and veterinary medicine. It uses
FDA Policy/General
Federal Register notice: FDA is seeking comments on a revised information collection on “Registration of Human Drug Compounding Outsourcing Facilities and Associated Fees Under Section 503B of the FD&C Act” (OMB Control Number 0910-0776). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection entitled “Medical Devices; Reports of Corrections and Removals — 21 CFR part 806” (OMB Control Number 0910–0359). The collection supports FDA regulations that require, within 10 working days of initiating any action to correct or remove a device to
Devices
HHS said 8/20 that under a Trump Administration deregulation initiative, FDA will no longer require premarket review of laboratory-developed tests (LDTs), including tests to detect the virus that causes Covid-19. It’s a major policy change made without notice and comment rulemaking. Attorneys Gail Javitt and Jeffrey
Biologics
Interviewed on WILX in Lansing, MI, FDA commissioner Stephen Hahn continued his efforts to reassure the public that there has been no political pressure on FDA to speed a vaccine approval and that only scientific data will be used to make such a decision. He reiterated that the speed in
Devices
An FDA 7/29 final guidance on the regulation of medical devices with multiple functions is largely similar to an earlier draft but with further clarification about the agency’s expectations for the device manufacturer risk assessment processes, including new language on assessing cybersecurity risks associated with non-device functions,
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a TV ad for Xeris Pharmaceuticals’ Gvoke (glucagon) injection for subcutaneous use makes false or misleading claims and representations about the risks associated with and efficacy of Gvoke. An 8/14 Notice of Violation says the violations are concerning from a