Biologics
The three Democratic leaders of the House Energy and Commerce Committee have written to FDA commissioner Stephen Hahn seeking assurance that science and the protection of public health will drive agency decisions to authorize or approve a Covid-19 vaccine, and not political expedience. The 8/24 letter was sent
Biologics
A 9/9-9/18/19 FDA inspection at Banco Vida Corp and Laboratorio Banco Vida, San Juan, Puerto Rico, determined that the firm manufactures human umbilical cord blood for allogenic use and that it recovers umbilical cord blood and processes an umbilical cord blood product in its facility. An
Drugs
A 2/10-2/19 FDA inspection at a Wintac Limited drug manufacturing facility in Bangalore, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 8/13 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a
Drugs
FDA commissioner Stephen Hahn has walked back his interpretation of data that supported the agency’s recent decision to grant an emergency use authorization (EUA) for Covid-19 convalescent plasma and its use in treating hospitalized Covid-19 patients (see earlier story). Hahn was widely criticized for misleadingly stating that
Drugs
AbbVie says it has submitted an application to FDA for a new indication for its Rinvoq (upadacitinib) 15 mg once daily to treat adult patients with active ankylosing spondylitis. A company statement says the application is supported by data from a Phase 2/3 study in which Rinvoq demonstrated significant
Devices
FDA has cleared a Gyroscope Therapeutics 510(k) for the Orbit Subretinal Delivery System, indicated for microinjection into the subretinal space at the back of the eye. The microinjection procedure is designed to avoid damaging the structure of the eye by preventing the need for a vitrectomy, a procedure that
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Banco Vida Corp., San Juan, Puerto Rico (8/12): FDA inspected the firm 9/2019 and cited significant deviations from current good manufacturing practice and current good tissue practice
Drugs
A new FDA study of 252 difficult-to-make prescription pharmaceuticals found that the U.S.-marketed products “consistently meet quality standards even when manufactured outside the U.S.” Published in the Journal of the American Medical Association Network Open, the study found that all 252 drug products the agency
Drugs
FDA says it is delaying collection of new drug manufacturing data to help it track potential drug shortages until an electronic data submission portal is established, which will not be ready by the 9/23 target date. The new reporting requirements are mandated under section 3112(e) of the Coronavirus
FDA Policy/General
FDA has issued a priority review voucher to Genentech for gaining approval of a rare pediatric disease product application — Evrysdi (risdiplam), indicated for treating patients two months of age and older with spinal muscular atrophy, a rare and often fatal genetic disease affecting muscle strength and movement. To view the
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