FDA Policy/General
Hyman, Phelps & McNamara has hired former CDER Office of Immunology and Inflammation director Julie Beitz as a principal drug regulatory expert. Beitz, an oncologist/hematologist, retired 7/29 from the agency after nearly 30 years of service. In her new role, Beitz joins attorneys and other regulatory experts to
Devices
[Commentary by Jim Dickinson] The recent exposure on this Web site of FDA 510(k) review corruption where favored companies’ devices get fast tracks to market while their competitors are slow-tracked or denied is testament to the need for an FDA definition of “substantial equivalence.” Since the term is
Drugs
Positive efficacy data have prompted Novo Nordisk to stop a kidney outcomes trial (FLOW) that was studying the effects of Ozempic (semaglutide) versus placebo on the progression of renal impairment in people with Type 2 diabetes and chronic kidney disease (CKD). The company says its decision to stop FLOW was
Biologics
A 10/2-10/10 FDA for-cause good clinical practice (GCP) inspection of Care Access’ activities in the Pfizer VALOR trial of an investigational Lyme disease vaccine resulted in no inspection observations and no issuance of a form FDA-483, according to a company statement. The inspection came after
FDA Policy/General
Federal Register notice: FDA has determined that the sterile dry powder excipient-free formulation of Baxter Pharmaceuticals’ Cytoxan (cyclophosphamide) for injection, and the sterile dry powder with sodium chloride formulation of Cytoxan (cyclophosphamide) for injection, were not withdrawn for safety or effectiveness reasons. The determination means that FDA can continue
Devices
FDA has cleared a DePuy Synthes 510(k) for the TriLEAP Lower Extremity Anatomic Plating System, a modular, procedure-specific device for use in orthopedic foot and ankle surgery. The device includes contoured and conventional plates that can accommodate multiple screw diameters, and instruments that can be used during the
Devices
A 3/1-4/13 FDA inspection at Abiomed in Danvers, MA, identified multiple violations in the firm’s manufacturing of several Impella pump Class 3 medical devices. A just-released 9/19 Warning Letter says the inspection found that the Impella Connect System device is adulterated because the company
Drugs
FDA has sent Warning Letters to two online marketers promoting unapproved glucagon-like peptide-1 receptor agonists semaglutide (Novo Nordisk’s diabetes and weight-loss drug under trade names Ozembic and Wegovy) and tirzepatide (Eli Lilly’s Mounjaro). “There are inherent risks to consumers who purchase unapproved new drugs and
Drugs
The Duke-Margolis Center for Health Policy says it supports any notion suggesting that several guidances issued by FDA on real-world data (RWD) and real-world evidence (RWE) and early conversations with the relevant agency review divisions should form the basis around uses of RWD/E to answer research
Drugs
FDA has released the form FDA-483 issued following a 2/8-3/24 inspection at Spectrum Laboratory Products, a New Brunswick, NJ, repacker/relabeler. The FDA-483 contains these 14 inspection observations: * failing to conduct repackaging operations under appropriate environmental conditions to avoid contamination and cross-contamination; * failing to
Devices
FDA says it has published minor updates to two magnetic resonance (MR)-related guidances to harmonize them with the latest edition of relevant FDA-recognized consensus standards. An agency notice (contains links to the guidances) says the updated guidances provide FDA’s recommendations on testing and labeling that should be
Drugs
An FDA Bioresearch Monitoring Program inspection at the clinical site maintained by Dr. Antonio Blanco/Vista Health Research in Miami, FL, found objectionable conditions that did not adhere to the requirements in the law and regulations governing the conduct of two clinical investigations and the protection of human subjects. A
Drugs
FDA says there is increased interest in compounded ketamine products, including oral formulations, for treating psychiatric disorders. An online post says patients and healthcare providers should know: * ketamine is not approved by the agency to treat any psychiatric disorder because it has not determined that the products are safe and
Drugs
The National Center for Health Research (NCHR) says that while an FDA guidance is needed to help sponsors develop labeling that includes clinically relevant information about the QTc interval, the guidance the agency has drafted “is too vague to be clinically useful or to meaningfully improve patient care.” In its
Devices
CDRH says it plans to publish four final guidances and 20 draft guidances in Fiscal Year 2024. An online document shows that on the A list of prioritized guidances, there are three final guidance topics and 18 draft guidance topics. On the B list of guidances to be published as
Drugs
The Regulatory Affairs Professionals Society (RAPS) says FDA is on schedule to publish a draft guidance on diversity plans before the end of this year. The society’s Regulatory Focus post says the guidance will take into consideration the unique challenges of conducting medical device clinical trials, citing an agency
Devices
FDA has cleared a Hyperfine 510(k) for updated software for its portable magnetic resonance brain imaging system, the Swoop system. The artificial intelligence (AI)-based software —"brings image quality enhancements to the Swoop system’s diffusion-weighted imaging (DWI) sequence,” Hyperfine says, adding that it expands the device’
Devices
FDA has released a final guidance entitled “Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.” The document is intended to harmonize with the 4th edition of the FDA-recognized standard IEC 60601-2-33 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance
Devices
FDA has approved Medtronic’s next-generation SynchroMed III intrathecal drug delivery system for patients with chronic pain, cancer pain, and severe spasticity. The device is described as a targeted drug delivery platform that alleviates symptoms by delivering medication directly to the fluid surrounding the spinal cord. “SynchroMed III is
Drugs
Merck says the Phase 3 KEYNOTE-671 trial evaluating Keytruda (pembrolizumab) as a perioperative treatment regimen for patients with resectable Stage II, IIIA or IIIB non-small cell lung cancer (NSCLC) met its dual primary endpoint of overall survival (OS). During a recent interim analysis, the company says “Keytruda plus
FDA Policy/General
Federal Register notice: FDA is publishing a list of 18 information collections that have been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. They are: * Premarket Notification Submission 510(k), Subpart E * Good Manufacturing Practice Regulations for Type A Medicated Articles * Tradeoff Analysis
Drugs
FDA has approved a Foundation Medicine PMA for its FoundationOne CDx to be used as a companion diagnostic for Eli Lilly’s Retevmo (selpercatinib), which was approved for treating adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior