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CDRH has posted a draft guidance on “Display Devices for Diagnostic Radiology” to assist industry in preparing premarket notification submissions for display devices intended for use in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
Drugs
FDA continues to be drawn into the drug pricing debate, with CDER director Janet Woodcock gaining unwanted attention as she sat at a witness table during a Congressional hearing with what media have dubbed the most hated man in America or on the Internet — former Turing Pharmaceuticals CEO Martin Shkreli.
Drugs
FDA commissioner-nominee Robert Califf and other agency officials have outlined a far-reaching action plan to reassess its approach to opioid medications. Presumably, the timing of the plan addresses a hold on Califf’s nomination by Sen. Edward J. Markey (D-MA), who called for immediate reforms to the
Drugs
FDA’s Psychopharmacologic Drugs Advisory Committee has voted 8 to 2 to recommend approving a Takeda supplemental NDA for Brintellix (vortioxetine) and its use in treating cognitive dysfunction in major depressive disorder. Before voting, panel members agreed that cognitive dysfunction in MDD is an appropriate drug target (see earlier story)
Drugs
CDER director Janet Woodcock is very concerned that the agency’s biosimilars program is going to “explode” with many high-profile applications potentially being submitted without adequate staff to process and review them. Testifying before a House Energy and Commerce health subcommittee hearing 2/4, Woodcock said that currently the