Devices
ICU Medical has begun a Class 1 recall of one lot of ChemoLock Vial Spikes, 20mm due to the potential for plastic particles to break off the protective cap. “In uncommon circumstances a plastic particle could enter the drug delivery system and be infused into a patient's intravenous
Devices
FDA has approved a Biotronik PMA for its Orsiro drug-eluting stent (DES) system. The company says the device is the first DES to outperform the clinical standard, Abbott’s Xience. Orsiro is indicated for use in percutaneous coronary intervention procedures. The cobalt chromium metal stent elutes sirolimus via BIOlute,
Drugs
FDA commissioner Scott Gottlieb and CDER director Janet Woodcock are defending the agency’s oversight of the generic drug industry to quash any doubt that generics are of lesser quality than branded drugs. In a 2/22 statement, the FDA leaders take exception to recent media reports suggesting FDA has
Drugs
An FDA drug safety review has concluded that an increased risk of death exists with Takeda’s Uloric (febuxostat) compared to another gout medicine, allopurinol. The conclusion is based on results from a safety clinical trial that found an increased risk of heart-related death and death from all causes
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products.” The document reflects the agency’s current recommendations on overall development programs to support nicotine replacement drug products for smoking cessation and related chronic indications. It focuses on
Drugs
FDA has approved changes to the prescribing information for Pfizer’s Chantix (varenicline) that specifies that the drug is not recommended for pediatric patients 16 years of age or younger because its efficacy in this population has not been demonstrated. Chantix is a nicotinic receptor partial agonist indicated for use
Devices
A 3/19-4/13/18 FFDA inspection at American Preclinical Services, Minneapolis, MN, found violations of Good Laboratory Practice regulations in the company’s participation in several nonclinical laboratory studies. A 2/12 Warning Letter corrects a Warning Letter issued 10/4/18. Inspection observations listed on an FDA-
Devices
FDA has cleared an Intuitive Surgical 510(k) for the Ion endoluminal system to enable minimally invasive biopsies in the peripheral lung. The device uses an ultra-thin articulating robotic catheter that can move 180 degrees in all directions. “The outer diameter of the catheter is 3.5 mm, which
Drugs
FDA has released a draft guidance on “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy (NRT) Drug Products.” The document reflects the agency’s current recommendations on overall development programs to support NRT drug products for smoking cessation and related chronic indications. It focuses on drug development and trial
Devices
FDA has cleared an Axilum Robotics 510(k) for the TMS-Cobot TS MV, indicated for the spatial positioning and orientation of the MagVenture Transcranial Magnetic Stimulation (TMS) Therapy system treatment coil. The device is based on the company’s new platform that uses a proprietary optical tracking system, which
Drugs
FDA has issued a proposed rule to update regulatory requirements for most sunscreen products in the U.S. The proposed rule is intended to bring nonprescription, over-the-counter sunscreens that are marketed without agency approved applications up to date with the latest science to better ensure that consumers have
Drugs
The Justice Department says four companies and three individuals have agreed to plead guilty to federal criminal charges related to illegally importing and selling $11 million worth of pharmaceutical-grade erectile dysfunction drugs falsely marketed as herbal remedies for men. A department news release also says two new cases were
Devices
FDA has issued a guidance, Acceptance and Filing Review for Premarket Approval Applications (PMAs), to help describe the broad preclinical and clinical issues that need to be addressed in a PMA and the key decisions to be made during the filing process. The document says that focusing the agency’s
Devices
FDA has issued a guidance, Refuse to Accept Policy for 510(k)s, to explain the procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review. “Focusing FDA’s review resources on complete
Devices
FDA is reminding stakeholders that 2/21 is the effective date for compliance with the final rule on Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices. The agency says the change will require that data submitted from clinical investigations outside the U.S. to support an
Devices
FDA has cleared an Agfa 510(k) for the DR 800 multipurpose imaging system with tomosynthesis. The device is intended to be one solution for radiography, fluoroscopy, multi-slice and advanced clinical applications. “With the DR 800, Agfa moves from 2D single plane imaging to multi-slice image reconstruction. Tomosynthesis
Drugs
An FDA final guidance on coordinated development of antimicrobial drugs and antimicrobial susceptibility test (AST) devices intends to describe the interactions that are needed to achieve coordinated development of applications submitted to CDER and CDRH, according to CDRH Division of Microbiology Devices branch chief Ribbi Shawar. Speaking at a CDRH
Drugs
An 8/7-8/9/18 FDA inspection at the Hangzhou Sunking Nonwovens drug manufacturing facility in Hangzhou, Zhejiang, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 1/29 Warning Letter says the specific violations were: * failing to have, for each
Drugs
A 2/21-2/24/18 FDA inspection at the Vipor Chemicals drug manufacturing facility in Vadodara, Gujarat, India, found significant deviations from current good manufacturing practices (CGMP) for active pharmaceutical ingredients. A just-released 1/29 Warning Letter says the specific deviations were: * failing to transfer all quality or
Drugs
FDA has placed a partial clinical hold on a Xencor a Phase 1 study of XmAb14045, a CD123 x CD3 bispecific antibody molecule being evaluated in patients with relapsed or refractory acute myeloid leukemia and other CD123-expressing hematologic malignancies. Patients currently on the therapy may continue treatment on the
Devices
CDRH associate director for digital health Bakul Patel says the 1/7 release of version 1.0 of the Center’s pre-certification working model also included release of a test plan and regulatory framework. In a 2/7 Webinar on the releases, Patel said that in version 1.0
FDA Policy/General
Federal Register notice: FDA has classified auto titration devices for oral appliances into Class 2 (special controls). This action follows a Zephyr Sleep Technologies request for de novo classification of the MATRx plus, which the agency identified as a prescription home use device that determines a target position to be