Drugs
FDA has approved Spark Therapeutics’ Luxturna (voretigene neparvovec-rzyl), a new gene therapy to treat children and adults with an inherited form of vision loss that may result in blindness. An agency news release says that Luxturna is the first directly administered gene therapy approved in the U.S. that
Drugs
FDA says it will take a new risk-based enforcement approach to drug products labeled as homeopathic. “To protect consumers who choose to use homeopathic products,” an agency news release says, “this proposed new approach would update FDA’s existing policy to better address situations where homeopathic treatments are being
Drugs
Sens. Chuck Grassley (R-IA) and Amy Klobuchar (D-MN) are asking FDA commissioner Scott Gottlieb whether the agency’s enforcement policies on prescription drugs imported from Canada has changed. The senators’ 12/21/17 letter follows an 11/20/17 Kaiser Health News report that FDA sent Office of
Devices
FDA has given 510(k) clearance to Xcision Medical Systems’ GammaPod stereotactic radiotherapy system intended to treat cancer in breast tissue. An agency news release notes that some 60% of all cancer patients are treated with some form of radiation therapy. The GammaPod system is intended for use in the
Devices
FDA is permitting marketing of Sanuwave’s Dermapace System, described by the agency as the first shock wave device intended to treat diabetic foot ulcers. An agency news release says the system is intended to be used to treat chronic, full-thickness diabetic foot ulcers with wound areas measuring no
Drugs
CDER innovative drug approvals sharply rebounded in 2017 — more than doubling the 22 products approved in 2016, which was a significant down year for approvals. In all, the Center approved 46 innovative NDA/BLAs last year. In contrast, there were just 22 approved in 2016 and 45 in 2015, according
Drugs
FDA has published a final guidance and a draft guidance addressing communications between the agency and drug sponsors. The final guidance, Best Practices for Communication Between IND Sponsors and FDA During Drug Development, describes best practices and procedures for timely, transparent, and effective communication between IND sponsors and FDA at
Drugs
Washington Legal Foundation (WLF) says that a 3rd Circuit Court of Appeals decision in a patent reverse payment case involving Pfizer and Ranbxy “represents a major expansion of antitrust law” and directly conflicts with the Supreme Court’s Actavis decision. In a brief asking the high court to hear Pfizer’
Drugs
FDA has issued a final rule establishing that 24 active ingredients in over-the-counter antiseptic products for use by healthcare professionals in a hospital setting or other healthcare situations outside the hospital are not generally recognized as safe and effective. The agency says it issued the final rule after
Drugs
FDA says it has updated the labeling for Novartis’ cancer drug Tasigna (nilotonib) to include information for providers about how to discontinue the drug in certain patients. An agency news release says Tasigna was approved in 2007 and is indicated for treating patients with Philadelphia chromosome positive (Ph+) chronic myeloid
Drugs
In a draft guidance, Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases, FDA says it no longer intends to grant orphan drug designation to drugs for pediatric subpopulations of common diseases unless use of the drug in the pediatric subpopulation meets the regulatory for
Devices
CDRH and CBER are proposing a Voluntary Malfunction Summary Reporting Program for manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form. A Federal Register notice says the proposed program reflects goals for streamlining malfunction reporting outlined in the MDUFA 4 commitment letter. The goals include permitting
Drugs
FDA has published a draft guidance, Information Requests and Discipline Review Letters under GDUFA, explaining how the agency will issue and use an information request (IR) and/or a discipline review letter (DRL) during review of an ANDA as contemplated in GDUFA 2. The document says the guidance does not
Drugs
FDA has approved La Jolla Pharmaceuticals’ Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock. An FDA news release says that in a clinical trial of 321 patients with shock and a critically low blood pressure, significantly more patients responded
Drugs
A 7/10-7/14/17 FDA inspection at Deserving Health International, Richmond, British Columbia, Canada, a manufacturer of sterile homeopathic eye drops, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. Specific violations cited in a 12/18/17 Warning Letter were: * failing to follow appropriate
Drugs
FDA says its review of four large clinical safety trials shows that treating asthma with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) does not result in significantly more serious asthma-related side effects than treatment with ICS alone. A drug safety communication says that in 2011
Devices
Physio-Control has recalled its defibrillation electrodes due to incorrect placement instructions for infants that were depicted on artwork. The Class 1 recall affects defibrillation electrodes used on the Lifepak Express AED, Lifepak CR Plus AED, Lifepak 1000 defibrillator, or Lifepak 500 Biphasic AED with a pink connector. Defibrillation electrodes
Devices
Sterilmed has begun a Class 1 recall of its Reprocessed Agilis Steerable Introducer Sheath due to an improper seal of the sheath hub. “Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that
Biologics
FDA has accepted for review a Seattle Genetics supplemental BLA for Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. The agency granted a priority review, and set a user fee review target date of 5/1. The submission is based
FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) has sent Vanthi (Newtown, PA) a Warning Letter objecting to a medical conference marketing panel for its Lomaira (phentermine hydrochloride USP) tablets. “This panel makes false or misleading claims and/or representations about the risks associated with Lomaira and omits material facts,
Drugs
FDA is requiring a new class Warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for MRIs. The Warning concerns retention of gadolinium in patients’ bodies, including the brain, for months to years after receiving the drugs. “Gadolinium retention has not been directly linked to adverse health
Drugs
A 3/6-3/9/17 FDA inspection at Prosana Distribuciones SA de CV, Mexico City, Mexico, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 12/18/17 Warning Letter says that specific violations were: * failing to have for each batch of drug product