Devices
FDA has cleared a LifeWatch AG 510(k) for its continuous Vital Signs Monitoring Service, a wireless patch intended to allow for early detection of vital sign changes. Notifications on vital sign changes can enable faster interventions as well as increased nursing efficiency and higher patient satisfaction, according to the
Drugs
“We are alarmed that the proposed budget will require FDA to choose among competing public health priorities, which is counter to the national interest and poorly serves the health and safety of the American people.” So asserted nonpartisan Alliance for a Stronger FDA vice president Troy Zimmerman in a 2/
FDA Policy/General
Federal Register Notice: FDA is publishing a list of PMAs that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management. To view this notice, click
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. ABC Productions Redondo Beach, CA (2/4). Reviewed Web site at www.calistores.com and www.cbdy.com in January. Misbranded: The claims on the Web sites establish that
Devices
CDRH has posted a draft guidance on “Display Devices for Diagnostic Radiology” to assist industry in preparing premarket notification submissions for display devices intended for use in diagnostic radiology. The document is intended to apply to current technologies, but the Center says it may request new or alternative test methods
Drugs
FDA has accepted for review an Otsuka Pharmaceutical Co. and H. Lundbeck A/S supplemental NDA for a proposed labeling update for Rexulti (brexpiprazole) and its use as maintenance treatment in adults with schizophrenia. The agency has set a user fee review target date of 9/23. The submission is
Drugs
An analysis by pharmacy researchers has revealed that the five most common drug recall reasons are contamination, mislabeling, adverse reactions, defective product, and incorrect potency. The analysis says compounding firms were associated more frequently with contamination than were noncompounding firms. The researchers had examined all FDA-issued recalls for drugs
Devices
FDA has posted a final guidance on “Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays” that discusses information to include in premarket notifications for assays for the anti-seizure drugs. The assays are intended to quantitatively measure concentrations of the respective drugs in serum or plasma as an aid
Drugs
FDA has placed a partial clinical hold on CTI BioPharma Corp. clinical studies being conducted under its IND for myelofibrosis drug pacritinib. The agency said the partial hold was ordered due to excess mortality and other adverse events in pacritinib-treated patients compared to the control arm in the PERSIST-
Drugs
Six patients claiming they were harmed by Johnson & Johnson’s Levaquin have filed a federal lawsuit in Washington, DC District Court against the company, former FDA commissioner Margaret Hamburg and her husband Peter Brown, alleging violations of the Racketeering and Corrupt Organizations Act, the Lanham Act, and a variety
Devices
FDA has cleared a Spectranetics 510(k) for the Bridge Occlusion Balloon for temporary vessel occlusion in cardiac lead extraction procedures. The device is designed to reduce blood loss if a tear occurs, including in the superior vena cava (SVC). The company says an SVC tear occurs in less than
Drugs
The Obama Administration says its “open data” initiative remains a priority in 2016. A White House blog posting acknowledges various OpenFDA updates, including direct downloads that enable citizens to use data on food, drug, and medical device safety. Open data from government agencies is an “important national resource, serving as
Drugs
FDA has extended by three months its review of a Sarepta Therapeutics NDA for eteplirsen, indicated for treating Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. The new user fee review target date is 5/26. The agency recently notified Sarepta that a 1/8 submission of four-year
FDA Policy/General
BIOLOGICS CBER Seeks Participants for Site Training Program Federal Register Notice: CBER is inviting biologics facilities to contact the Center for more information on participating in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity
Devices
FDA has approved Medtronic’s Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan defibrillators for patients requiring magnetic resonance imaging (MRI). The approvals cover MRI scans on any part of the body without positioning restrictions, the company says. Until now, CRT-Ds have been contraindicated
Biologics
FDA reviewers have concluded that Celltrion’s proposed biosimilar (CT-P13) is highly similar to Janssen’s Remicade (infliximab), notwithstanding minor differences in clinically inactive components. This finding was summarized in briefing documents released in advance of a 2/9 advisory committee review on the latest biosimialr product to obtain
Drugs
FDA has approved an Avanir Pharmaceuticals NDA for Onzetra Xsail (sumatriptan nasal powder), formerly known as AVP-825, for the acute treatment of migraine with or without aura in adults. The intranasal medication delivery system comprises a low-dose (22mg) of sumatriptan powder that is delivered utilizing the Xsail Breath
Drugs
A U.S. Supreme Court decision last June involving First Amendment arguments in a case about township sign codes has certain implications for how FDA regulates off-label promotion, according to Reed and Smith attorneys. Writing in a recent Washington Legal Foundation Legal Backgrounder, they say the decision “significantly affects
Drugs
FDA has approved an expanded indication for Bristol-Myers Squibb’s Daklinza (daclatasvir, 60 mg) — combination use with sofosbuvir (with or without ribavirin) in hepatitis C virus genotypes 1 and 3. The expanded label includes data in three additional challenging-to-treat patient populations: chronic hepatitis C virus (HCV) patients
Drugs
CDER’s Office of Generics Drugs has released a “dashboard” report designed to improve transparency and communication as it implements the Generic Drug User Fee Amendments of 2012 (GDUFA). The report includes a current submission status on the last three years’ Application Cohorts and the “total original ANDA workload activity”
Drugs
FDA has issued Vertex Pharmaceuticals a complete response letter on a supplemental NDA for the use of Kalydeco (ivacaftor) in people with cystic fibrosis (CF) ages two and older who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. FDA’s letter said
Drugs
Former Pfizer executive John LaMattina says that legislation introduced last year by Sen. Ted Cruz (R-TX) to change how FDA approves drugs would actually likely hurt the drug industry. Writing in a Forbes online opinion column, LaMattina says that Cruz’ Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act