Drugs
FDA’s new draft guidance on “Real-World Evidence (RWE): Considerations Regarding Non-Interventional Studies for Drug and Biological Products” provides “additional clarity” on the agency’s focus when analyzing a RWE program’s adequacy, according to an online post from attorneys at Hogan Lovells. “Notably, unlike previous guidances on
Drugs
Organon is asking FDA to impose requirements on any ANDAs that cite its Nexplanon (etonogestrel implant) as the reference-listed drug. The company’s 3/1 petition asks that the agency specifically: * require that an ANDA applicant establish bioequivalence (BE) of the generic drug through (1) an in vivo BE
Drugs
FDA has released the form FDA-483 issued following a 5/15-5/26/2023 inspection at Medi-Fare, a Blacksburg, SC, outsourcing facility. The four inspection observations were: * reports of analysis from component suppliers are accepted instead of testing each component for conformity with all appropriate written specifications, without
Drugs
FDA has granted in part and denied in part a 2016 petition from the Center for Responsible Science asking that the agency issue a guidance communicating broadly that it will accept in vitro primary skin and eye irritation data and that in vivo rabbit ocular and skin irritation tests (Draize)
Devices
AdvaMed has given FDA 44 proposed edits to the agency’s draft guidance on the characterization of metallic coatings and/or calcium phosphate coatings on orthopedic devices. The association’s specific line-by-line suggestions are displayed in a 14-page table.
Drugs
FDA has approved safety labeling changes for fluorouracil injection drug products. An online post says the Office of Generic Drugs and Oncology Center of Excellence collaborated on the revisions. Fluorouracil injection was first approved in 1962, the post says. FDA became aware of additional safety information on the risk of
Devices
Vyaire Medical is recalling (Class 1) certain AirLife Manual Resuscitators due to a manufacturing defect. “Using the recalled resuscitators could result in patients not receiving enough ventilation,” a recall notice says. “In some cases, patients may not receive any ventilation. People who don’t get adequate ventilation may not be
Devices
House Energy and Commerce Health Subcommittee chair Brett Guthrie (R-KY) told a 3/21 hearing that he cannot support FDA’s proposed rule on oversight of laboratory-developed tests (LDTs) and said it should be withdrawn while legislative proposals are crafted to address outstanding challenges with such devices. “As
Drugs
Merck says its Phase 3 KEYLYNK-006 trial evaluating Keytruda (pembrolizumab), an anti-PD-1 therapy, in combination with maintenance Lynparza (olaparib), a PARP inhibitor, did not meet its primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of certain patients with metastatic
Drugs
Abiomed is recalling (Class 1) its Impella Left Sided Blood Pumps because the pump catheter may slice the heart’s left ventricle wall during operations. “The use of the affected Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood
Devices
FDA has granted Elixir Medical a breakthrough device designation for its DynamX BTK System, an adaptive implant for use in treating narrowed or blocked vessels below the knee (BTK) in patients with chronic limb-threatening ischemia (CLTI). The company says DynamX is the only metallic device “designed to support the
Devices
The FDA Ophthalmic Devices Panel will discuss on 3/21 the de novo request from Balance Ophthalmics, Inc., for its FSYX Ocular Pressure Adjusting Pump. An agency briefing document released before the meeting says the device has a set of goggles connected to a pump. When the goggles are worn,
Drugs
A 4/25/2023 virtual public meeting sponsored by FDA on “Long Covid” focused on several key themes raised by patients, their caregivers, and other patient representatives. A 3/2024 meeting report says some 3,200 people attended the meeting whose discussion focused on: * health effects and daily impacts of
Drugs
Attorneys Dominick DiSabatino and Arushi Pandya (SheppardMullin) say FDA’s publication of a draft guidance on key information and facilitating understanding in informed consent may mean the agency will soon finalize its 9/28/2022 proposed rule that will harmonize FDA regulations with the HHS common rule on the protection
Drugs
FDA has published a draft guidance, Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products, with recommendations for sponsors and investigators who are considering submitting a non-interventional study to the agency to contribute to a demonstration of substantial evidence of effectiveness and/or evidence of
Biologics
CBER has launched a Web page describing its approach to artificial intelligence and machine learning (AI/ML) for biological and other products regulated by the Center. The page says the Center has participated in public workshops and discussions organized by FDA and other national and international organizations to better understand
Devices
FDA has cleared a Fujifilm Healthcare Americas 510(k) for CAD EYE, an artificial intelligence detection system for endoscopic imaging. The device provides real-time detection of colonic mucosal lesions such as polyps and adenomas during colonoscopy procedures, supporting endoscopists in their ability to detect and remove pre-cancerous lesions,
Devices
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Drugs
FDA has approved an Idorsia NDA for Tryvio (aprocitentan) for treating hypertension in combination with other antihypertensive drugs in adult patients who are not adequately controlled on other drugs. Aprocitentan is described as an endothelin receptor antagonist that inhibits the binding of endothelin (ET)-1 to ETA and ETB receptors.
FDA Policy/General
Federal Register notice: FDA is proposing to establish criteria for the lists of drug products or drug categories that present demonstrable difficulties for compounding under certain sections of the Federal Food, Drug, and Cosmetic Act. Additionally, the agency is proposing to identify the first three categories of drug products on
Drugs
FDA has approved Johnson & Johnson’s Edurant PED (rilpivirine) for treating HIV-1 in combination with other antiretroviral therapies (ARVs) in treatment-naïve children at least two years of age and weighing at least 14 kg and less than 25 kg. The approval is based on data from the
Drugs
FDA has issued Warning Letters (see below) to Jiangsu Shenli Medical Production Co. Ltd, a China-based plastic syringe manufacturer, and Medline Industries and Sol-Millennium Medical, two firms marketing and distributing in the U.S. plastic syringes made in China. “All three Warning Letters describe violations related to the