Drugs
Former CDER Office of Process & Facilities director Robert Iser has joined Parexel as vice president of regulatory consulting services, where he will help clients avoid market delays due to compliance or quality problems. Iser spent more than 15 years at the agency. Most recently, he was responsible for reviewing
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” The document discusses changes in policies and procedures surrounding the user fee assessment and collection for biosimilar manufacturers. To view the notice, click here.
Devices
FDA has cleared a Voluntis 510(k) for Insulia, a “digital companion” for people with Type 2 diabetes that the sponsor says can integrate Lilly’s Basaglar and Novo Nordisk’s Tresiba insulin products. According to the company, this now makes Insulia available for people using any brand of basal
Drugs
Public Citizen is petitioning FDA to withdraw from the market all medications containing the angiotensin II receptor blocker (ARB) olmesartan medoxomil (Daiichi Sankyo’s Azor, Benicar, Benicar HCT, and Tribenzor, with all generics of these drugs). The advocacy group petition says that olmesartan medoxomil is associated with a risk of
FDA Policy/General
The National Antimicrobial Resistance Monitoring System (NARMS) annual report for 2015 says that while overall resistance remains low for most human infections and there have been measurable improvements in resistance levels in some important areas, the system is “closely monitoring a few areas of concern.” An agency news release says
Devices
The Federal Trade Commission (FTC) has finalized a consent order it says is designed to remedy the anticompetitive effects resulting from Abbott’s $8.3 billion acquisition of Alere. Under the order, the parties will divest two of Alere’s point-of-care medical device product lines — point-of-care
Drugs
Baxter International has recalled one lot of Nexterone (amiodarone HCl) 150 mg/100 mL premixed injection due to the potential presence of particulate matter which may have entered the solution during the manufacturing process, a recall notice says. “The particulate matter was identified by Baxter during a stability study, and
Drugs
A Phase 3 study by Acorda Therapeutics of tozadenant for Parkinson’s disease could be in jeopardy after the company reports five deaths in the study and recommending increased frequency (weekly) of blood cell count monitoring for trial participants. The increased monitoring is in response to cases of agranulocytosis, possibly
Drugs
An FDA drug safety alert says that Takeda’s gout drug Uloric (febuxostat) may have an increased risk of heart-related death when compared to allopurinol (Mylan’s Aloprim and Casper Pharma’s Zyloprim). This is the preliminary finding from an FDA-required safety study conducted by Takeda. “Once the
Biologics
FDA has posted a draft guidance on “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” The document explains changes to the user fee program mandated under the Reauthorization Act of 2017, particularly the new fee structure and types of fees for which entities are responsible. It describes
Drugs
FDA has cleared an Alcyone Lifesciences 510(k) for the Alivio Ventricular Catheter and Flusher System for treating hydrocephalus. This comes on the heels of Alcyone receiving the EU CE Mark last month. The device is intended to provide clinicians with the option of non-invasive retrograde flushing of the
Drugs
FDA has approved an Ultragenyx Pharmaceutical NDA for Mepsevii (vestronidase alfa-vjbk), the first approved treatment for pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome. MPS VII is an extremely rare, progressive condition that affects most tissues and
FDA Policy/General
FDA commissioner Scott Gottlieb says an FDA Hiring Initiative will reimagine the agency’s hiring practices and procedures with the goal of attracting, recruiting, and hiring and retaining professionals who support FDA’s mission. Writing in an FDA Voice blog post, Gottlieb says a comprehensive evaluation of hiring practices and
Devices
FDA has authorized Memorial Sloan Kettering Cancer Center’s IMPACT (integrated mutation profiling of actionable cancer targets) tumor profiling test, an in vitro diagnostic assay that can identify a higher number of biomarkers than may be found in various cancers with any test previously reviewed by the agency. IMPACT was
Drugs
A 3/27-4/7 FDA inspection at the Lupin Limited drug manufacturing facility in Goa, India, and a 5/8-5/19 inspection at the facility in Indore, Madhya, Pradesh, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals at each plant, according to an
FDA Policy/General
FDA direct-to-consumer ad researchers say their content analysis of 50 television direct-to-consumer (DTC) prescription drug ads airing between 7/2012 and 8/2014 suggests an unintended consequence of a focus on risk completeness without an accompanying focus on understandability. The study analysis is reported in the
Drugs
FDA has approved an Otsuka Pharmaceutical NDA for mental disorder-treating Abilify MyCite (aripiprazole tablets with sensor) — the first drug-device combination in the U.S. with a digital ingestion tracking system. The pill has a sensor embedded in it that records when the medication was taken. It is approved
Devices
FDA has issued a safety alert about illegal use of injectable silicone for body contouring and associated injuries and disfigurement that can result from such products. The agency says the injectable silicone products are being falsely marketed as FDA-approved dermal fillers for the purpose of enhancing the size of
FDA Policy/General
Federal Register notice: FDA has classified the automated indirect immunofluorescence microscope and software-assisted system into Class 2 (special controls). The classification is in response to a 2014 de novo classification request from Inova Diagnostics for its NOVA View Automated Fluorescence Microscope. The agency is codifying the classification by adding
Devices
CDRH associate director for science and strategic partnerships Suzanne Schwartz says medical device manufacturers have made “a fair amount of progress that has been very encouraging” in dealing with cybersecurity issues. In an audio interview with the Information Security Media Group, Schwartz says the agency has seen industry be “more
Drugs
FDA commissioner Scott Gottlieb says the agency has issued a public health advisory related to growing concerns about risks associated with use of a botanical substance known as kratom. In a statement, Gottlieb emphasizes that there are no FDA-approved products containing kratom and that no drug manufacturer has filed
Drugs
Yale University and Johns Hopkins University School of Medicine researchers say FDA’s 2006 Unapproved Drugs Initiative (UDI) intended to strengthen the agency’s regulatory oversight of unapproved marketed drugs has led to significant increases in drug prices after UDI regulatory action or approval. Writing in the Journal of the