FDA Policy/General
FDA commissioner Stephen Hahn says that over the past year the agency has seen about 1,000 net growth in staff due to a streamlined hiring spree authorized by the recent CURES Act. “For FY 20, the FDA hired 2,308 staff (and lost 1,281) with a total net
Drugs
FDA has issued Adamis Pharmaceuticals another complete response letter (CRL) on its NDA for Zimhi, a high-dose naloxone injection product for treating opioid overdose. The letter provided recommendations to support the NDA’s resubmission. “The questions raised by the FDA related generally to new chemistry, manufacturing and controls issues,
Devices
FDA has made available a draft guidance entitled Electromagnetic Compatibility (EMC) of Medical Devices. The document provides recommendations about information that should be provided in medical device submissions to demonstrate the EMC for electrically powered devices with electrical or electronic functions. The agency says that typically the review of EMC
Drugs
Federal Register notice: FDA has made available a final guidance #197 entitled Documenting Electronic Data Files and Statistical Analysis Programs. The document provides recommendations for documenting electronic data files and statistical analyses submitted to CVM to support new animal drug applications. To view the notice, click here.
Drugs
FDA has issued Sanofi a complete response letter (CRL) on its BLA for sutimlimab, an investigational monoclonal antibody for treating hemolysis in adults with cold agglutinin disease. The letter refers to deficiencies identified by the agency during a pre-license inspection of an unnamed third-party facility responsible for manufacturing,
FDA Policy/General
Oncologic Panel to Review GSK Myeloma BLA Federal Register notice: FDA announces a 12/14 online/teleconferencing Oncologic Drugs Advisory Committee meeting that will review a GlaxoSmithKline BLA for belantamab mafodotin, indicated for treating certain adults with relapsed or refractory multiple myeloma. 11/13/2020 Notice Corrected on ANDAs Withdrawn
Drugs
Boston Scientific has agreed to pay $75 million for some of the manufacturing assets and capabilities of Neovasc, which makes products for the cardiovascular market, including components for transcatheter heart valves such as Boston Scientific’s Lotus Valve System. Boston Scientific developed Lotus for transcatheter aortic valve replacement in order
Drugs
CDER director Janet Woodcock, who has been temporarily assigned to work with the Trump administration’s Operation Warp Speed, says the nation’s medical infrastructure has learned things during the Covid-19 pandemic that should lead to changes in the way things are organized for future infectious disease problems. Participating
Drugs
Heron Therapeutics has resubmitted to FDA its NDA for HTX-011, an investigational agent for managing postoperative pain. A company statement says the NDA was resubmitted based on the outcome and final minutes of a September Type A end-of-review meeting with the agency that discussed what was needed
Devices
FDA has granted 510(k) clearance for the use of Lantheus’ artificial intelligence-enabled automated bone scan index product on the GE Healthcare Xelerix platform. The company describes it as a vendor-neutral standalone software as a medical device that calculates the automated bone scan index in Technetium-99m bone
Drugs
Two suits filed by Nexus Pharmaceuticals against two drug compounding firms were dismissed by a California federal court under implied preemption as stated in Buckman v. Plaintinffs Legal Committee. Attorney James Beck (Reed Smith) says in an online post that the court said the suits were preempted because Nexus challenged
Drugs
FDA has granted orphan drug designation for Agios Pharmaceuticals’ first-in-class pyruvate kinase R (PKR) activator mitapivat for treating patients with sickle cell disease. The company says mitapivat is an investigational, oral, small molecule allosteric activator of wild-type and a variety of mutated PKR enzymes. It previously was
Drugs
The Justice Department says a Virginia federal court sentenced Indivior Solutions to pay $289 million in criminal penalties in connection with a previous guilty plea related to its marketing of Suboxone. The judge entered the sentence under a plea agreement. Altogether, a Justice Department statement says, Indivior Solutions will pay
FDA Policy/General
The Alliance for a Stronger FDA says the president’s FY 21 budget request for FDA, the House-passed bill, and the Senate’s new proposed bill have similar funding levels and a common core of initiatives for the agency to carry out in the new fiscal year if, as
FDA Policy/General
Federal Register notice: FDA is contemplating the grant of an exclusive patent license to Advion, Inc. (Ithaca, NY) for a government-owned patent for “Direct Impact Ionization Mass Spectrometry.” The license is limited to the manufacture and commercialization of a field-deployable mass spectrometer diagnostic for the rapid detection of
Drugs
FDA has posted an 11/6 safety labeling change for Genentech’s multiple sclerosis drug Ocrevus (ocrelizumab). The change affects the label’s Warnings and Precautions, Adverse Reactions, Use in Specific Populations, and Patient Counseling/Patient Information/Medication Guide sections.
Drugs
FDA’s recent emergency use authorization (EUA) for Eli Lilly’s investigational monoclonal antibody therapy bamlanivimab for treating mild-to-moderate Covid-19 in adult and pediatric patients (see earlier story) contains GMP-related conditions the company must maintain due to concerns raised in two inspections conducted at its manufacturing
Drugs
FDA has awarded a research project to staff at the University of Maryland Smith School of Business to look at the risks to industry and government of returning drug manufacturing to the U.S. A statement from the university says the research will examine advanced manufacturing as a pathway to
FDA Policy/General
FDA has published a guidance, Documenting Electronic Data Files and Statistical Analysis Programs, to inform sponsors of recommendations for documenting electronic data files and statistical analyses submitted to CVM to support new animal drug applications. The document says its recommendations are intended to reduce the number of revisions that may
Drugs
FDA has cleared a SafKan Health 510(k) for its OtoSet Ear Cleaning System for removing impacted earwax. The device is an alternative to the time-tested ear bladder syringe. The device features a combination “irrigation and microsuction technology built into an automated and wearable device.” The company says it
Devices
Members of the FDA Ophthalmic Devices Panel voted 11/9 to recommend against approval of the Refocus Group’s VisAbility Micro Insert System with a proposed indication for bilateral scleral implantation to improve unaided near vision in phakic, presbyopic patients between 45 and 60 years old with specified manifest spherical
Devices
FDA says the Cook Medical 10/14 recall of its fixed core wire guide is Class 1. An agency statement says Cook recalled the product because five lots of wire guides dropped onto an unchecked surface during production. The notice said the drop could cause the wire guide to bend