Devices
FDA says it has extended to 8/18 the deadline for comments on a discussion paper on “Conveying Materials Information about Medical Devices to Patients and Healthcare Providers.” An agency notice (includes a link to the paper) says the document is intended to help FDA gather feedback from the public
Drugs
Real-world data involving Gilead Sciences’ Veklury (remdesivir) show that the therapy offered a lower mortality risk in hospitalized Covid-19 patients. Data from three retrospective real-world data studies show a reduction in mortality was “observed across a spectrum of baseline oxygen requirements,” the company says. For example, one
Biologics
FDA has released a final guidance entitled Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products. The document is intended to help biologic manufacturers/sponsors in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls information to an approved BLA. It describes
Devices
FDA has approved a Medtronic PMA supplement for expanded approval for its Arctic Front Cardiac Cryoablation Catheters to include treating recurrent symptomatic paroxysmal atrial fibrillation (episodes that last less than seven continuous days) as an alternative to antiarrhythmic drug (AAD) therapy as an initial rhythm control strategy. The expanded indication
Biologics
FDA has sent an untitled letter to NatureWorks (Poulsbo, WA) after reviewing the Web sites www.natureworksacupuncture.com and www.stemcells-washington.com, as well as other information, about its marketing of cellular products derived from human umbilical cords. The letter objects to the products being offered for treating serious
Devices
FDA has cleared a Masimo 510(k) for the Radius T, a wearable, wireless thermometer that measures body temperature continuously. The device is described by Masimo as being compatible with both the Root Patient Monitoring and Connectivity Hub and the Rad-97 patient monitor for use in the hospital, as
Drugs
James Chadwick Brooks (Norcross, GA) and his company CCB Nutrition have pleaded guilty to introducing an unapproved new drug into interstate commerce with the intent to defraud and mislead FDA. The government contends that from 2016 to 2019, Brooks marketed supplements containing anabolic steroids such as androsterone, trestolone, epiandrosterone and
Drugs
Tarsus Pharmaceuticals says it is planning an NDA submission next year after just reporting positive data from a Phase 2b/3 trial (Saturn-1) that evaluated the company’s novel investigational therapeutic, TP-03 (lotilaner ophthalmic solution, 0.25%), in patients with demodex blepharitis. The company says the highly prevalent
Drugs
FDA says it proposed FY 2022 budget requests an increase of $38 million above the current year’s enacted level to support CDER and CDRH activities involving the opioid crisis. In an online post, FDA acting commissioner Janet Woodcock says the agency’s work going forward will address four priority
Drugs
FDA has approved Boehringer Ingelheim Pharmaceuticals’ Pradaxa (dabigatran etexilate) oral pellets to treat children aged three months to less than 12 years with venous thromboembolism directly after they have been treated with a blood thinner given by injection for at least five days. It also approved the drug for preventing
FDA Policy/General
Guide on Premenopausal Women with Breast Cancer 6/17/2021 Federal Register notice: FDA has made available a final guidance entitled Premenopausal Women with Breast Cancer: Developing Drugs for Treatment. The document provides recommendations about including premenopausal women in breast cancer clinical trials. To view the notice, click here. Progressive
FDA Policy/General
FDA’s controversial decision to provide accelerated approval to Biogen’s Alzheimer’s drug illustrates the need to disrupt the status quo at FDA and nominate someone other than acting commissioner Janet Woodcock, Senator Joe Manchin (D-WV) said in a 6/17 letter to President Biden. Noting the scientific
Devices
FDA has granted Spinologics a breakthrough device designation for its MIScoli system, a vertebral body tethering device to treat scoliosis in young adolescents. The device is being developed as an alternative to spine fusion when adolescents need a surgical intervention to correct a curvature of the spine. The company says
Drugs
FDA has granted Roche an emergency use authorization for its cobas SARS-CoV-2 nucleic acid test for use on the cobas Liat System. The company says the singleplex test is the first real-time reverse transcriptase polymerase chain reaction test that can identify SARS-CoV-2 infection within 20
Drugs
FDA has issued Orphazyme a complete response letter on an NDA for arimoclomol, a heat shock protein amplifier intended for treating Niemann-Pick disease Type C (NPC). In the letter, the agency requested “additional qualitative and quantitative evidence to further substantiate the validity and interpretation of the 5-domain NPC
Drugs
FDA has approved Bayer Healthcare’s Astepro (azelastine hydrochloride nasal spray, 0.15%), a nasal antihistamine for nonprescription use under an Rx-to-OTC switch. Astepro is indicated for treating seasonal and perennial allergic rhinitis for adults and children six years of age and older. The approval is a first-
Devices
Smiths Medical has begun a Class 1 recall of specific models and lots of Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes that may have skewed odd number line graduation markings on their syringe barrels. Markings skewed about 20 degrees upward have been identified, a recall notice says. “As a
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Premenopausal Women with Breast Cancer: Developing Drugs for Treatment. The document provides recommendations about including premenopausal women in breast cancer clinical trials. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 9/21 public workshop entitled “Considerations for Progressive Multifocal Leukoencephalopathy Clinical Trial Designs.” The workshop is intended to discuss the challenges and clinical trial design considerations for developing therapeutic products for treating progressive multifocal leukoencephalopathy. To view the notice, click here.
Drugs
Bausch Health is petitioning FDA not to approve any ANDA submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act that cites Duobrii as the reference-listed drug unless the application meets all the specifications sought by the company. The 5/28 petition asks that the agency
Devices
FDA has issued a draft guidance, Remanufacturing of Medical Devices, to help clarify whether activities performed on devices are likely “remanufacturing.” The document says such clarification is intended to help provide consistency and better understanding of applicable statutory and regulatory requirements. The draft also includes recommendations for information that should
Devices
FDA says Philips issued a 6/14 recall notification to mitigate potential health risks related to the sound abatement foam in its bi-level positive airway pressure, continuous positive airway pressure, and mechanical ventilator devices. An agency notice says company testing determined there are possible risks to users related to