Drugs
FDA has granted MediciNova an orphan drug designation for MN-166 (ibudilast) for treating amyotrophic lateral sclerosis (ALS). Currently, the company has two ongoing clinical trials that are evaluating MN-166 in ALS in collaboration with researchers at Carolinas HealthCare System’s (CHS) Neuromuscular/ALS-MDA Center and Massachusetts General
Devices
FDA has cleared a BioFire Diagnostics 510(k) for the FilmArray Respiratory Panel EZ. The device is intended for use in detecting 11 viral and three bacterial pathogens associated with respiratory infections from a single patient sample. It is designed to run on the FilmArray 2.0 system and provides
Drugs
AstraZeneca says it has stopped a Phase 2a trial for asthma therapy AZD9412 (inhaled interferon beta) based on an interim analysis that found an “overall very low number of reported severe exacerbations” that could make primary endpoint conclusions difficult. “The interim analysis confirmed the positive safety and tolerability profile seen
Drugs
FDA says it has identified more than 10 lots of oral liquid docusate sodium manufactured by PharmaTechm, Davie, FL, as the source of a multistate outbreak of Burkholder cepacia. An agency safety update says its investigation also detected B. cepacia in the water system used to manufacture the product. The
FDA Policy/General
Federal Register Notice: FDA has made available a guidance entitled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.” The document describes studies and criteria that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring systems which are for prescription point-of-
Devices
FDA says that internal analyses on the use of Alere’s faulty blood testing devices (INRatio and INRatio 2 PT/INR) had a “minimal” impact on a clinical trial involving Johnson & Johnson’s blood thinner Xarelto. “The agency has determined that effects on strokes or bleeding, including bleeding in
Drugs
A 1/18-1/22 FDA inspection at China’s Yangzhou Hengyuan Daily Chemical Plastic Co. found significant violations of current good manufacturing practice regulations, according to a 9/26 Warning Letter. Specific violations included: * failing to provide adequate written production and control procedures that are designed to assure that
Drugs
A 6/20-6/23 FDA inspection at Laboratoire Sintyl, Geneva, Switzerland, found numerous violations of current good manufacturing practice for finished pharmaceuticals, according to a 9/29 Warning Letter. Specific violations included: * failing to establish written policies and procedures applicable to the quality control unit, including the review of
Drugs
The Third Circuit Court of Appeals has sided with a Pennsylvania federal court’s ruling that the Sheller law firm lacks standing to bring suit to compel FDA to approve its petition over the use of Janssen’s Risperdal (risperidone) and generic forms of the drug in children. Sheller represents
Biologics
FDA has approved a Protein Sciences BLA for its quadrivalent formulation of Flublok influenza vaccine, which protects against four strains of influenza, three of the same strains found in trivalent Flublok plus an additional B strain. Approval was based on data from a clinical study of 9,000 adults 50
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. CFP Acquisitions, Inc. (dba The Apothecary Shoppe) Broken Arrow, OK (8/19). FDA inspected pharmacy compounding operations in March and noted that the firm was not receiving valid prescriptions
Drugs
The Massachusetts federal court has dismissed an indictment charging two former New England Compounding Center employees with felony counts of dispensing drugs into interstate commerce without a valid prescription. Attorney Andrew Hull (Hyman, Phelps & McNamara) writes in his firm’s FDA Law Blog that the controversial aspect of the
Drugs
Rep. Ron DeSantis (R-FL) has introduced the Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act of 2016 (H.R. 6241), to provide for reciprocal marketing approval of certain drugs, biological products, and medical devices that are authorized to be lawfully marketed abroad but not in the U.S.
Devices
An FDA safety communication says that St. Jude Medical has issued an advisory on implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator batteries that may fail earlier than expected. FDA and the company are alerting patients, patient caregivers, and doctors to respond immediately to elective replacement indicator alerts on the
FDA Policy/General
Federal Register Notice: FDA has released a guidance on “Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process” for panels convened to determine whether a sunscreen active ingredient or combination of sunscreen active ingredients is generally recognized as safe and effective and should be added to the over-the-counter
FDA Policy/General
Federal Register Notice: FDA has made available a guidance on “Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request.” The document provides recommendations for the process for withdrawing a 586A request submitted under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by
FDA Policy/General
Federal Register Notice: FDA has made available a guidance entitled “Self-Monitoring Blood Glucose Test Systems for Over- the-Counter Use.” The document describes studies and criteria that FDA recommends be used when submitting premarket notifications (510(k)s) for self-monitoring blood glucose test systems intended for over-the-
Biologics
FDA has granted Gamida a breakthrough therapy designation for its NiCord cellular therapy based on data showing improvement in absorption of neutrophils blood cells in bone marrow transplant for patients with high risk hematological malignancies (blood cancers). NiCord is an ex vivo expanded cell graft, utilizing Gamida’s proprietary NAM
Drugs
Mylan has agreed to the terms of a $465 million settlement with the U.S. Department of Justice and other government agencies to resolve questions that have been raised about the classification of EpiPen Auto-Injector and EpiPen Jr. Auto-Injector under the Medicaid Drug Rebate Program. “The terms of
Drugs
FDA has sent Nicox a complete response letter (CRL) on its NDA for AC-170 (cetirizine), an eye drop formulation for treating ocular itching associated with allergic conjunctivitis. The letter cited a GMP inspection at a third party facility producing the active pharmaceutical ingredient as the reason for not approving
Devices
FDA has cleared a St. Jude Medical 510(k) for the PressureWire X Guidewire fractional flow reserve (FFR) measurement system, which is designed to offer improved shapeability and better shape retention aimed at reducing vessel trauma during percutaneous coronary intervention procedures. The measurement system is intended for use by physicians
Devices
A citizen petition from the law firm Wood, Herron & Evans urges FDA to detain Magnacoustics’s MagnaTouch MRI Music System, Genesis Ultra MRI Music System and MagnAlarm because they are not cleared by the agency under a 510(k). The petition says the devices are “clearly accessories to magnetic