Drugs
FDA has placed on partial clinical hold a Kura Oncology Phase 1b study (KOMET-001) of KO-539 in patients with relapsed or refractory acute myeloid leukemia (AML). The hold is the result of the company’s recent report to the agency about a Grade 5 serious adverse event (patient
FDA Policy/General
Federal Register notice: FDA is issuing an order permanently debarring Maytee Lledo from providing services in any capacity to a person that has an approved or pending drug product application. The agency contends that while LLedo was employed at Sacred Heart Medical Office in Florida during 2013 through 2016, she
FDA Policy/General
Federal Register notice: FDA is classifying the general laparoscopic power morcellation containment system into Class 2 (special controls). FDA is also codifying the classification by adding 21 CFR 878.4825.1, which is identified as a prescription device consisting of an instrument port and tissue containment method that creates a
Drugs
Sagent Pharmaceuticals has recalled four lots of levetiracetam injection due to container closure integrity concerns. “Intravenous administration of a product intended to be sterile that is not sterile could result in serious systemic infections which may be life threatening,” a recall notice says. To date, Sagent says it has not
Drugs
The Sedgwick Recall Index for the third quarter of 2021 says both medical device and pharmaceutical recalls “surged.” The index says medical device recalls rose 35.8% from 173 in the previous quarter to 235. And drug recalls surged by 45.8% from 59 last quarter to 86. Software issues
Drugs
FDA has extended for three months to 2/28/2022 the PDUFA action date for Amryt’s NDA for Oleogel-S10 to treat cutaneous manifestations of junctional and dystrophic epidermolysis bullosa (EB). FDA said the extension was needed to give it time to review additional analyses of data previously submitted
Drugs
The Government Accountability Office (GAO) says that since FDA established the limited population pathway for antibacterial and antifungal drugs (LPAD) in 2016, drug developers have formally requested approval under it for four drugs, two of which were approved. In a report, GAO says FDA and stakeholders agreed that LPAD’s
Drugs
Research conducted by FDA scientists will inform efforts to improve pediatric dose selection strategies for drug developers and pediatricians who must pay particular attention to renal function. An online agency post says renal function models and equations are valuable tools for predicting drug pharmacokinetics, clearance, and dose adjustments in pediatric
Devices
Two medical device technical experts at Hyman, Phelps & McNamara say an 11/4 FDA draft guidance describes the recommended documentation that a sponsor should include in premarket submissions for medical device software functions. Writing in their firm’s FDA Law Blog, the two say the draft, when finalized, will
Biologics
The House Select Committee on the Coronavirus Crisis is asking former FDA commissioner Stephen Hahn for information relating to possible political interference from the Trump administration in the pandemic response. In an 11/22 letter, the committee asks Hahn for all documents and communications in his possession, custody, or control
Drugs
FDA has granted Isofol Medical a fast track designation for arfolitixorin, a stabilized and biologically active pure form of folate ([6R]-MTHF) for treating patients with metastatic colorectal cancer. Arfolitixorin is designed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. It is currently being studied
FDA Policy/General
New financial disclosure documents showing Robert Califf earning millions of dollars last year from industry could throw a wrench in the confirmation process for the Biden Administration’s pick to lead FDA. “Califf has cashed in on the revolving door both going into government and back out again into the
Drugs
Four Sidley attorneys say an FDA draft guidance on benefit/risk assessment for new drugs and biological products “is [so] groundbreaking in its articulation of a vision of drug development that many entities involved in developing innovative drugs and biological products should review it carefully.” In an online post, the
FDA Policy/General
Federal Register notice: FDA is issuing a final order to reclassify three types of blood lancets used to puncture skin to obtain a drop of blood for diagnostic purposes from Class 1 (general controls) exempt from premarket notification into Class 2 (special controls) and subject to premarket notification. The affected
FDA Policy/General
Federal Register notice: FDA is issuing a final order to reclassify certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative detection of HCV, from Class 3 devices (product code MZO) into Class 2 (general controls and special controls), subject to premarket notification. FDA is also renaming and
FDA Policy/General
Federal Register notice: FDA is issuing a final order to reclassify nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, from Class 3 devices (product codes MZP and OBF) into Class 2 (general controls and special
FDA Policy/General
Federal Register notice: FDA has extended the comment period for a 9/24 over-the-counter monograph proposed order entitled “Amending Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use.” Comments now should be submitted by 12/27. To view the notice, click here.
Drugs
FDA has accepted for priority review a bluebird bio BLA for betibeglogene autotemcel (beti-cel), a gene therapy for adult, adolescent and pediatric patients with β-thalassemia across all genotypes who require regular red blood cell (RBC) transfusions. If approved, beti-cel would be a one-time treatment that addresses
Drugs
FDA has accepted for review an Obseva NDA for linzagolix for managing heavy menstrual bleeding associated with uterine fibroids in premenopausal women. Linzagolix is described as an GnRH receptor antagonist with flexible dosing options for uterine fibroids, including a low dose option to address the needs of women who cannot
Devices
FDA has granted Theradaptive a breakthrough medical device designation for its Osteo-Adapt SP Spinal Fusion implant indicated for transforaminal lumbar interbody spinal fusion to treat degenerative disc disease, spondylolisthesis, or retrolisthesis. The company says the implant is designed to permit precise tissue regeneration for a variety of tissue types
Drugs
FDA appears to be making progress in the backlog of inspectional work needed to render review decisions on outstanding medical product applications that were delayed due to the Covid-19 pandemic. In May, the agency released its “Resiliency Roadmap for FDA Inspectional Oversight” report (see earlier story) that said 68
FDA Policy/General
Valeant Pharmaceuticals and EyeGate Pharmaceuticals have entered into a licensing agreement through which EyeGate has granted a subsidiary of Valeant exclusive, worldwide commercial and manufacturing rights to the EyeGate II Delivery System and EGP-437 combination product candidate for treating post-operative pain and inflammation in ocular surgery patients. This