Drugs
FDA has placed two Chinese and two Indian companies on import alert that bans their products from being shipped into the U.S. because they failed to submit self-identifying information or pay facility fees required under the Generic Drug User Fee Act. This is the first time the agency
FDA Policy/General
Federal Register Notice: FDA is making available the “Foods and Veterinary Medicine Program’s Strategic Plan for Fiscal Years 2016-2025” that covers activities of the Office of Foods and Veterinary Medicine, the Center for Food Safety and Applied Nutrition, and the Center for Veterinary Medicine as related efforts by
FDA Policy/General
Federal Register Notice: FDA has determined that Parafon Forte DSC (chlorzoxazone) tablets, 500 mg were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow the agency to continue to approve ANDAs for chlorzoxane tablets, 500 mg, if all other legal and regulatory requirements are met.
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Bacterial Vaginosis: Developing Drugs for Treatment. Its purpose is to assist sponsors in the clinical development of drugs for treating bacterial vaginosis (BV). It helps define enrollment criteria for BV trials and recommends that such trials be
FDA Policy/General
Federal Register Final rule: FDA is amending its regulations by removing certain ones that include obsolete references. In the 2/12 Federal Register (81 FR 7445), FDA published a final rule entitled “Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972.” FDA, in part,
FDA Policy/General
FDA has awarded Information Innovators Inc. a $100 million Web content management system support services contract. The five-year “blanket purchase agreement” expands on the company’s continued work for the agency. “With its $100 million ceiling, the contract calls for the organization to support the exponential growth of fda.
Drugs
FDA has posted a draft guidance on “Bacterial Vaginosis: Developing Drugs for Treatment” that should assist sponsors in their overall clinical development program and clinical trial designs to support drugs for such indications. It focuses only on developing antibacterial drugs for treating symptomatic bacterial vaginosis (BV). “There are epidemiological associations
Drugs
FDA says that its analyses so far on the use of Alere’s faulty blood testing devices (INRatio and INRatio 2 PT/INR) appear to have had “minimal” impact on a clinical trial involving Johnson & Johnson’s blood thinner Xarelto. “Our analyses so far indicate that effects on strokes
Drugs
FDA researchers say that a survey they conducted shows an increasing trend in the evaluation of transporter-mediated drug-drug interactions (DDIs) either during drug development or post-approval. Writing in The Journal of Clinical Pharmacology, the researchers say that their observation may be a reflection of recent interest in
Devices
FDA has denied a 1/7 petition from Biorex Labs seeking exemption from the premarket notification requirements for its copper reduction tablet test that measures glucose in urine. The denial letter says that such tests are used in diagnosing and treating carbohydrate metabolism disorders and says that such tests require
Devices
EP Vantage says in an online post that FDA approved 19 first-time PMAs and HDEs in the first half of 2016, down slightly from the 26 approved in the comparable period in 2015. “Perhaps the large companies have been too preoccupied with integrating their acquisitions to have put the
Drugs
Imarc Research says in an online post that the release of FDA and European Medicines Agency guidances on incorporating risk management strategies in the clinical research industry, sets an expectation for implementation of quality principles and risk-based decision-making. “It is the responsibility of the industry to incorporate these
Devices
FDA has approved a Medtronic PMA supplement for the IN.PACT Admiral drug-coated balloon (DCB) in longer (150 mm lengths), which will be available in four, five, and six mm diameters, for treating long lesions in patients with peripheral artery disease. “The long lesion (10-18 cm) sub-group
FDA Policy/General
Federal Register Final order: FDA is classifying the metallic biliary stent system for benign strictures into Class 2 (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the metallic biliary stent system for benign
Drugs
FDA has denied three separate petitions asking it to take specific actions relating to labeling for biosimilar products and has said it will consider the petitions’ requests as part of comments received on a draft guidance on the topic. The agency says that given the subject matter overlap between the
Drugs
The full Appeals Court for the Federal Circuit has rejected application of the on-sale bar to contract manufacturers, paving the way for specialty companies to use outside vendors to manufacture their inventions. (An on-sale bar provides that an invention cannot be patented if it was for sale more
Drugs
FDA’s Arthritis Drugs Advisory Committee has voted 20 to 0 to support approval for a Sandoz BLA (GP2015) for a biosimilar copy of Amgen’s Enbrel (etanercept). The panel recommended approval for the therapy to treat all five of Enbrel’s indications — rheumatoid arthritis, plaque psoriasis, psoriatic psoriasis, ankylosing
Biologics
FDA has approved a Pfizer BLA supplement for Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) for an expanded age indication to include adults 18 through 49 years of age for active immunization for preventing pneumonia and invasive disease caused by 13 Streptococcus pneumoniae serotypes (1, 3, 4,
Drugs
In a positive sign for Juno Therapeutics and other developers of promising CAR-T cell product candidates, FDA has removed a clinical hold on Juno’s Phase 2 clinical trial of JCAR015 (ROCKET trial) in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia. The agency placed the
Devices
Writing in a Journal of the American Medical Association column, FDA commissioner Robert Califf and CDRH director Jeffrey Shuren say that a “national evaluation system that engages all stakeholders could enable FDA to focus efforts on facilitating the development and interpretation of more informative data essential for policy-making and
Drugs
FDA has approved a Shire NDA for Xiidra (lifitegrast ophthalmic solution) for treating dry eye disease signs and symptoms. Xiidra is the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 (LFA-1) antagonist, according to an agency release. Approval was based on data from
Devices
Alere Inc. says it will be initiating a voluntary withdrawal of its controversial INRatio and INRatio 2 PT/INR Monitoring Systems due to concerns about inaccurate test results. Last year, Public Citizen reported that the blood testing devices, used in a trial of Bayer’s Xarelto overseen by a steering