FDA Policy/General
Federal Register Notice: FDA is issuing a revised draft guidance for industry entitled Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. It supersedes a 7/2011 draft guidance on the same topic. The revised draft guidance, when finalized, will help industry in evaluating whether to submit a premarket safety
Devices
FDA has posted two final guidances on electrosurgical device submissions. The guidance on Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery is intended for devices designed to seal isolated blood and lymphatic vessels for hemostasis (as an alternative to ties) through the use of high-
Devices
BioMerieux has begun a Class 1 recall of its NucliSENS easyMAG Magnetic Silica (MagSil) because of effects on nucleic acids extraction performance. MagSil is used to extract and purify genetic material from patient samples. “Kits with the affected lots of the Magnetic silica have exhibited a decrease of extraction performance
Devices
The Advanced Medical Technology Association (AdvaMed) says FDA’s draft guidance on “Technical Considerations for Additive Manufactured (AM or 3-D Printed) Devices” is confusing regarding recommendations on patient-matched devices (patient-specific, personalized or customized). In just-posted comments to the agency, AdvaMed says that to “mitigate this confusion,
Drugs
Ton Shen Health of Chicago, IL, has recalled its “DHZC-2” tablets because they have the potential to be contaminated with elevated levels of lead. One illness has been reported to date in connection with this problem, according to a recall notice. The sale of the product has been suspended
Drugs
FDA has completed a comprehensive review of safety information related to fatty acid amide hydrolase (FAAH) inhibitors under development in the U.S and determined that toxicity seen with a similar drug in France does not extend to others in the drug class. Earlier this year, the agency and European
Drugs
The Clinical Trials Transformation Initiative (CTTI) has published two sets of recommendations intended to advance clinical trials for antibacterial drug development to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). A CTTI statement says that the new recommendations “outline innovative approaches to designing clinical trials for
Drugs
Attorney Mark Schwartz (Hyman, Phelps & McNamara) says it is “troubling that FDA has been so delinquent in developing a framework to more objectively assess the strength of quality systems throughout the [drug] industry, which could have identified such problems in their infancy, and done so more accurately.” Schwartz’ comment
Drugs
FDA has published a draft guidance, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry, to help manufacturers and distributors of dietary ingredients and dietary supplements decide whether to submit a premarket safety notification to FDA for a product that is or contains a new dietary ingredient
Drugs
Actavis is asking FDA to assign an AP therapeutic equivalence code to its Azacitidine for Injection, 100 mg/vial, which was approved 4/29 in a 505(b)(2) NDA. The petition says that the product meets all applicable requirements for therapeutic equivalence and interchangeability with Celgene’s Vidaza (azacitidine
Drugs
FDA has released the FDA-483 issued at the end of a 7/11-7/22 inspection at Advanced Pharma, Houston, TX. Specific inspection observations included: * failing to establish procedures to prevent microbiological contamination of drug products purporting to be sterile; * failing to have written test procedures relative to appropriate
FDA Policy/General
Federal Register Notice: FDA is extending the comment period until 9/12 for the document entitled “Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers; Draft Guidance for Industry and Food and Drug Administration Staff,” that appeared in the 5/13
FDA Policy/General
Federal Register Final rule: FDA is amending its regulations to correct an error in the lists of statutory and regulatory provisions that provide an opportunity for an informal hearing in connection with a ban of a device. In the list of statutory provisions at Sec. 16.1(b)(1), the
FDA Policy/General
Federal Register Final rule: FDA is making technical corrections to its regulations for hearing procedures for denial of approval or withdrawal of approval of new animal drug applications. FDA is revising Sec. 514.200 to make its language and terminology consistent with the language and terminology of the procedural regulations
Devices
FDA has cleared a D R Burton Healthcare Products 510(k) for its iPEP system, an oscillating positive expiratory pressure product. The device is intended to measure patient inspiratory capacity, according to the company. It combines two standard of care therapies — “the inspiratory capacity measurement associated with an incentive spirometer
Drugs
Australia-based Novogen has submitted an IND for TRX-E-002-1 (cantrixil) for treating ovarian cancer. The submission includes data on preclinical pharmacology and toxicity, manufacturing, quality control, and clinical development plans. Cantrixil is described as a first-in-class development candidate which is being studied as a therapy
Drugs
FDA has approved a Heron Therapeutics for Sustol (granisetron) extended-release injection, a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline
Devices
Sanuwave Health has submitted a de novo petition requesting CDRH review and classification of the dermaPACE System for treating diabetic foot ulcers as a Class 2 device. The submission is based on data from two clinical trials involving 336 patients. The trial’s primary endpoint was wound closure, which was
Drugs
The 2nd Circuit Court of Appeals has upheld a New York federal court ruling that granted Acorda Therapeutics’ motion to dismiss an Apotex anti-trust claim and also granted summary judgment to Acorda on Lanham Act false advertising claims. The appeals court decision says the case concerned two distinct questions:
Drugs
FDA has given Eisai the green light to move its early Alzheimer’s disease drug E2609 into Phase 3 clinical studies. During a recent end-of-Phase 2 meeting, the agency confirmed there were sufficient data to support the advancement of the novel investigational oral beta-secretase cleaving enzyme (BACE)
Drugs
Eli Lilly says that after a pre-planned interim analysis of its MONARCH 2 study involving abemaciclib, an independent Data Monitoring Committee recommended to continue the study without modification because the interim efficacy criteria were not met. The study compares abemaciclib plus fulvestrant versus placebo with fulvestrant in women with
Drugs
OpenTrialsFDA says it is working to make FDA drug approval packages (DAPs) from the agency Web site easily searchable and accessible and to link them to documents and data related to clinical trials. In a description of their work, the app developers say that DAPs are published at an agency