Drugs
The Clinical Decision Support Coalition is asking FDA for guidance that answers specified questions arising out of three case studies developed by the coalition on issues around a risk-based and clearly defined regulatory system for clinical decision support software that appropriately balances the need for regulatory oversight with the
Drugs
Aerie Pharmaceuticals has filed an NDA for Rhopressa (netarsudil ophthalmic solution) 0.02%, a novel once-daily eye drop designed to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. The filing includes data from two Phase 3 registration named Rocket 1 and Rocket 2. The company says
Devices
An FDA safety communication alerts women to risks associated with using tests marketed as ovarian cancer screening tests. The alert says that the agency is especially concerned about delaying effective preventive treatments for women who show no symptoms but still are at increased risk for developing ovarian cancer. “Despite extensive
Devices
FDA has cleared an Invendo Medical 510(k) for the invendoscopy E200 System, which includes the invendoscope SC200, a sterile, single-use colonoscope. The device features robotic assistance for tip control and a new design to offer gastroenterologists (GIs) greater control. It is cleared to provide visualization and diagnostic/therapeutic
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Requests for Clinical Laboratory Improvement Amendments of 1988 Categorization — 42 CFR 493.17,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is seeking comments on the information collection requirements for agency regulations related to human cells, tissues, and cellular and tissue-based products (HCT/Ps) involving establishment registration and listing using Form FDA 3356; eligibility determination for donors; and current good tissue practice. Comments should be submitted
FDA Policy/General
Federal Register Notice: FDA is issuing an Emergency Use Authorization for a Viracor-IBT Laboratories’ in vitro diagnostic device for detecting the Zika virus in response to the Zika virus outbreak in the Americas. To view this notice, click here.
Drugs
FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), an anti-PD-1 therapy for first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1. The agency has set a user fee review target date of 12/24.
Biologics
The Southern Florida District Court has ruled that Apotex’s proposed filgrastim and pegfilgrastim biosimilar products will not infringe the asserted claims of Amgen’s ’138 patent (U.S. Patent. No. 8,952,138). Apotex had contended that the process described in its aBLAs falls outside the scope of the
Drugs
FDA has granted Taxis Pharmaceuticals a qualified infectious disease product designation for TXA709, which targets acute bacterial skin and skin structure infections caused by Staphylococcus aureus, including methicillin-resistant strains. TXA709 is a prodrug that produces a derivative of benzoic acid that disrupts the form and function of the bacterial
FDA Policy/General
Federal Register Notice: FDA is requesting comments on its tentative conclusion that vinpocetine is not a dietary ingredient and is excluded from the definition of dietary supplement in the FD&C Act. Comments should be submitted by 11/7. To view this notice, click here.
Drugs
FDA has just released the FDA-483 that was issued at the conclusion of a 2/8-2/25 inspection at Bausch & Lomb’s facility in Tampa, FL. Specific violations noted on the form included: * failing to include conclusions and follow-up in written records of investigations into unexplained
Drugs
An 8/10/15-8/13/15 FDA inspection at Zhejiang Hisoar Pharmaceutical Co., Taizhou City, China, found current good manufacturing practice and data integrity violations in the firm’s manufacturing of active pharmaceutical ingredients, according to an 8/11 Warning Letter. Specific violations included: * failing to maintain complete data
Drugs
A Louisiana federal court says that three state liability claims against Janssen over its diabetes drug Invokana may proceed toward trial. The judge ruled in a case brought by a woman who claims the drug caused her kidneys to fail. Her initial suit was dismissed for lack of specificity, but
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on the application for participation in the Medical Device Fellowship Program. Comments should be written by 11/7. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications — 21 CFR Part 3,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click
FDA Policy/General
Federal Register Notice: FDA has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. It will allow the agency to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
FDA Policy/General
Federal Register Final rule: FDA is issuing a final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water are not generally recognized as safe and effective and are misbranded. FDA is issuing this final rule after considering the recommendations
Drugs
FDA has extended by three months the review of a Novo Nordisk NDA for IDegLira, a fixed-dose combination of Victoza (liraglutide), a glucagon-like peptide-1 receptor agonist, and Tresiba (insulin degludec), a long-acting insulin analog. The company submitted the NDA 9/2015, and with the review extension
Drugs
AstraZeneca says recent Phase 3 data demonstrated that adding benralizumab to standard-of-care medicine significantly reduced exacerbations and improved lung function and asthma symptoms in severe asthma patients with an eosinophilic phenotype, which is detected by the presence of eosinophils in the blood. The SIROCCO and CALIMA trials evaluated
Devices
CDRH director Jeffrey Shuren says FDA and other international regulatory agencies are considering how to develop a harmonized premarket review system. Providing a Center update at the Alliance for a Stronger FDA in Washington, DC 9/6, Shuren said the harmonized review would be modeled after the Medical Device Single
Devices
CDRH says it has approved an updated postmarket study plan submitted by Bayer to assess safety and efficacy issues involving its controversial birth control device Essure. The study was ordered by the agency earlier this year to determine heightened risks for particular women. FDA believes that “results collected from the