Drugs
FDA has granted Awak Technologies a breakthrough designation for its Awak Peritoneal Dialysis device, a wearable and ultra-portable peritoneal dialysis system that uses the company’s patented sorbent technology. The device is intended to allow dialysis to be performed “on-the-go,” overcoming the challenge of long hours of
Devices
FDA has cleared an Empatica 510(k) for its Embrace, a pediatric epilepsy smartband that detects patterns in motion and physiological signals that may be associated with generalized tonic-clonic seizures, and immediately alerts caregivers. The company says it is the first non-EEG based physiology signal seizure monitoring system
FDA Policy/General
Seven former FDA commissioners who served more than 30 years total in both Democratic and Republican administrations say the agency should be taken away from HHS and reconfigured into an independent federal agency. The seven spent 18 months examining FDA’s position within the federal government, its reporting relationships and
FDA Policy/General
As FDA enters the third week of the partial government shutdown, agency employees still on the job are facing challenges with fulfilling public health responsibilities, according to the Alliance for a Stronger FDA. The group has created an “FDA Shutdown Toolkit” that explains how agency operations are affected. During the
Devices
FDA has approved a MicroVention (a Terumo subsidiary) PMA for the WEB Aneurysm Embolization System for treating intracranial wide neck bifurcation aneurysms. The company says the device is the only PMA-approved device in the new category of intrasaccular flow disruptors for aneurysm embolization. PMA approval is based on data
Drugs
U.S. Supreme Court justices 1/7 appeared to be leaning in Merck’s favor in its arguments for reversing a 3rd Circuit Court of Appeals ruling that allowed hundreds of state-based liability claims involving alleged failure to adequately warn of fracture risk associated with Fosamax (alendronate sodium) to
Devices
FDA has cleared a Neocis 510(k) for additional dental materials to be used with Yomi, the company’s robot-assisted dental surgery system. Yomi provides computerized navigation to assist in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. “The system offers physical
Devices
FDA has issued a new Software Precertification (Pre-Cert) Pilot Program working model 1.0, Test plan, and regulatory framework to explain how it envisions regulating digital health devices by looking at information across the total product lifecycle. The pilot is now entering the test phase that will allow FDA
Drugs
Lupin Pharmaceuticals has recalled five lots of ceftriaxone for injection (250mg), 10 lots of ceftriaxone for injection (500mg), 24 lots of ceftriaxone for injection (1g) and three lots of ceftriaxone for injection (2g) because the products have been found to contain visual grey particulate matter in reconstituted vials. “Improper piercing
Drugs
CDER saw a 28% increase in novel new drug approvals last year — jumping from 46 approvals in 2017 to 59 in 2018. In contrast, over the past ten years CDER has averaged about 33 novel drug approvals per year, according to a just-released report. A close look at the
Drugs
FDA has granted Rainier Therapeutics a fast track designation for its targeted antibody vofatamab for treating patients with advanced or metastatic urothelial cell carcinoma (bladder cancer) that is positive for FGFR3 mutation or fusion. Vofatamab (B-701) is an antibody specifically targeted against the fibroblast growth factor receptor 3 (FGFR3)
FDA Policy/General
FDA Webview has posted below the Federal Register notices published during our annual end-of-year holiday break. DEVICES Federal Register final rule: FDA has issued a final rule to amend its regulations governing medical device classification and reclassification to conform to the applicable provisions of the Food, Drug, and
FDA Policy/General
DEVICES FDA has cleared a Myoscience 510(k) for its iovera device for relieving pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The device uses iovera’s technology and non-systemic treatment for blocking pain signals from peripheral nerves. It uses the “body’s
Drugs
FDA has granted CRISPR Therapeutics and Vertex Pharmaceuticals a fast track designation for CTX001 for treating sickle cell disease. The companies are developing the investigational, autologous, gene-edited hematopoietic stem cell therapy for patients suffering from severe hemoglobinopathies. Late last year, they filed an IND for a Phase 1/2
FDA Policy/General
FDA has announced that former Flatiron Health chief medical officer Amy Abernethy will replace retiring Rachel Sherman as the agency’s principal deputy commissioner. Previously, Abernethy served as a professor at Duke University School of Medicine and directed the Center for Learning Health Care in the Duke Clinical Research Institute.
Drugs
Torrent Pharmaceuticals has expanded an earlier recall from two lots of hypertension drug losartan potassium tablets USP to a total of 10 lots due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient manufactured by Hetero Labs. Torrent is only recalling lots of
Drugs
FDA has accepted a Nabriva Therapeutics NDA and granted a priority review for Contepo (fosfomycin for injection) to treat complicated urinary tract infections (cUTIs), including acute pyelonephritis. The agency has set a 6/30 review action target date. The 505(b)(2) submission is supported by data from the Phase
Devices
Endologix says it is discontinuing unrestricted sales of its Nellix stent graft for treating abdominal aortic aneurysms and limiting its use to pre-screened patients under a clinical protocol. The company is recalling all existing inventory data, and use under the protocol will first be pre-screened by a panel
Drugs
Verrica Pharmaceuticals says it is planning an NDA submission in the second half of the year for VP-102 for treating molluscum contagiosum, a highly contagious skin disease affecting primarily children. The submission will be based on just-reported data from the company’s Phase 3 CAMP-1 and CAMP-
Devices
Akonni Biosystems has filed a 510(k) to market the TruDiagnosis system, its proprietary microarray-based technology. The company says the in vitro diagnostic device is intended for genotyping multiple genes in a DNA sample using on-slide polymerase chain reaction gel-drop microarray technology to help detect clinically relevant
Drugs
FDA and the American Society for Clinical Pharmacology and Therapeutics are co-sponsoring a 3/13 conference on “PBPK Modeling for the Development and Approval of Locally Acting Drug Products.” In announcing the conference, the agency says “recent advancement of physiologically-based PK (PBPK) models for drugs delivered directly to
Drugs
FDA has approved a StemCyte IND to conduct a Phase 2 trial of its Allogeneic Human Leukocyte Antigen-Matched Umbilical Cord Blood Mononuclear Stem Cells (MC001) for treating spinal cord injury. The regenerative cell therapy drug is designed to regenerate neurons in patients who suffered chronic, severe, stable spinal cord