Devices
FDA has cleared an Xtant Medical Holdings 510(k) for the Xspan Laminoplasty Fixation System and its use in the lower cervical and upper thoracic spine (C3-T3). Spinal laminoplasty is a surgical procedure performed to remove pressure from the spinal cord, according to the company. “Unlike a laminectomy, where
Drugs
Republican leaders of the House Energy and Commerce Committee say that even with intensified FDA efforts to protect heparin, “serious challenges remain to significantly reduce risks for heparin from economically-motivated adulteration.” In a 3/29 letter to FDA commissioner Robert Califf, the congressmen lay out five key problems identified
Biologics
FDA says an investigational test is available for use under an IND to screen donated blood in areas with active mosquito-borne transmission of Zika virus. An agency news release says that the Roche Molecular Systems test was developed in close collaboration with FDA. In a 2/18 guidance to
Drugs
The Justice Department says Novartis has violated a Corporate Integrity Agreement it signed following the $422.5 million settlement of a 2010 case against the company over its drug promotional practices, and should now be hit with each tougher penalties. The government says the company engaged in a nationwide kickback
Drugs
FDA has approved a supplemental NDA for Danco Laboratories’ abortifacient Mifeprex (mifepristone) to relax label requirements for administering the drug. The approval expands on-label usage to 70 days after a woman’s last menstrual period. Previously, the label recommended the drug be used within 49 days of the last
FDA Policy/General
Federal Register Final rule: FDA is amending the animal drug regulations to reflect application-related actions for NADAs and ANADAs during 11/2015 and 12/2015. The agency is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
Drugs
FDA has approved a Jazz Pharmaceuticals NDA for Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities after receiving a hematopoietic stem cell transplantation (HSCT). Hepatic VOD can occur in patients who receive chemotherapy and HSCT, according to
Drugs
FDA says that during Fiscal Year 2015, it met or exceeded many of the goals established for the Generic Drug User Fee Amendments (GDUFA) program. The program’s FY 2015 performance report says the agency met or exceeded its hiring goal, exceeded the commitment to respond to 70% of GDUFA
Drugs
The Securities and Exchange Commission (SEC) has brought fraud charges against Aveo Pharmaceuticals and three of its former executives for misleading investors about company efforts to obtain FDA approval for its kidney cancer drug tivozanib. The SEC says the company hid the level of FDA concern about the drug in
Drugs
FDA’s Psychopharmacologic Drugs Advisory Committee has voted 12 to 2 to support approval of an Acadia Pharmaceuticals NDA for Nuplazid (pimavanserin) and its use in treating psychosis associated with Parkinson’s Disease (PDP). Agency reviewers had noted that data submitted showed that pimavanserin 40 mg was more efficacious than
FDA Policy/General
FDA commissioner Robert Califf says that one of his highest priorities in leading the agency is to encourage and support a professional environment that enables the staff to thrive and to reach its full potential. Writing in an FDA Voice blog post, Califf says that his workforce initiative is intended
FDA Policy/General
Federal Register Notice: FDA is establishing a public docket to make available to the public a report of the pediatric studies of lorazepam that were conducted in accordance with the Public Health Service Act and submitted to the director of the National Institutes of Health and FDA commissioner. Comments should
Drugs
A 9/15-10/7/14 FDA inspection at Leiter’s Compounding, San Jose, CA, found current good manufacturing practice and other violations in the firm’s work as an outsourcing facility and determined that the company is producing drugs that violate the Federal Food, Drug, and Cosmetic Act, according
Devices
FDA says a 6/2015 recall by OxySure Therapeutics involving its OxySure replacement cartridges for the OxySure Portable Emergency Oxygen System Model 615 was ineffective. A new agency alert recommends that consumers, businesses, schools, and health care providers stop using the devices because of several device malfunctions, including ineffective oxygen
Devices
CDRH has added four new learning modules on unique device identifiers to its online learning catalog “CDRH Learn.” The new modules are: 1. Unique Device Identification (UDI) System Regulatory Overview (New module 3/29/16) Presentation Printable Slides Transcript 2. Global Unique Device Identification Database (GUDID) Account Request: Preparation and
FDA Policy/General
Federal Register Notice: FDA is establishing a public docket to make available to the public a report of the pediatric studies of lorazepam that were conducted in accordance with the Public Health Service Act and submitted to the director of the National Institutes of Health and FDA commissioner. Comments should
Drugs
FDA has issued Newron Pharmaceuticals a complete response letter on an NDA for safinamide, indicated for treating patients with Parkinson’s disease. The letter requests “clinical evaluation of the potential effect of safinamide on behaviors relating to abuse liability and dependence/withdrawal effects” as required by CDER’s Controlled Substance
Drugs
B. Braun Medical has recalled one lot of 5% dextrose injection USP 100/150mL container (Lot #J5J706) after it identified an adverse quality trend in customer complaints reporting that some containers exhibited leakage. The company also says it has received complaints about visible particulate matter identified as microbial growth. “To
Drugs
Pain Therapeutics has resubmitted to FDA an NDA for Remoxy (oxycodone) extended-release capsules, an abuse-deterrent formulation for treating pain. The submission was made despite Pfizer deciding in 2014 to discontinue its agreement to develop and commercialize Remoxy due to unresolved issues outlined in a 2011 complete response letter
Drugs
FDA has approved a Boehringer Ingelheim Pharmaceuticals supplemental NDA for Stiolto Respimat (tiotropium bromide and olodaterol) that adds to the label data showing improvement in health-related quality of life among people with chronic obstructive pulmonary disease (COPD). Approval is based on data from the OTEMTO 1 and 2 clinical
Drugs
FDA has issued Takeda Pharmaceutical Co. and H. Lundbeck A a complete response letter for a supplemental NDA for Brintellix (vortioxetine) that sought to include new data in the drug’s clinical trials labeling section for treating certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD). The
Drugs
Since 2010, FDA has issued Warning Letters to an increasing number of companies for data integrity violations, according to an analysis by the PricewaterhouseCoopers Health Research Institute, reported in a March Regulatory Spotlight. From 2010 to 2012, it says, five drug manufacturers were cited for data integrity violations, while from