FDA Policy/General
Federal Register Notice: FDA is amending the 2/19 notice of meeting of the Pediatric Advisory Committee to reflect a change in the Location portion of the document. On page 8508, in the first column, the Location portion of the document is changed to read as follows: DoubleTree by Hilton
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Invokana (canagliflozin) is 2,137 days for extending a patent which claims the human drug product. Invokana is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus. To view
Devices
FDA has cleared a Tyber Medical 510(k) for its BioTy, a modified surface treatment for use on its Headless Screw System. “The technology modifies the surface characteristics of medical devices for advanced indications yet to be disclosed, but under development through the FDA review process,” the company says. In
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Argo Medical Technologies, Inc. Marlborough, MA (9/30). Misbranded: FDA authorized marketing of the ReWalk device under a de novo classification 6/26/14 and ordered Argo to conduct
Biologics
FDA says that due to considerable interest in a scheduled 4/13 public hearing on a draft guidance relating to regulation of human cells, tissues, or cellular- or tissue-based products, it is extending the comment period for the draft guidance documents and postponing the hearing until later this year.
Drugs
FDA says it will exercise enforcement discretion under limited conditions for IND requirements for using fecal microbiota transplantation (FMT) to treat C. difficile infection not responding to standard therapies. A draft guidance, Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile
Devices
The Justice Department says that Olympus Corp. of the Americas, the nation’s largest distributor of endoscopes and related equipment, will pay $623.2 million to resolve criminal charges and civil claims relating to a scheme to pay kickbacks to doctors and hospitals. A company subsidiary also will pay $22.
FDA Policy/General
FDA associate commissioner for regulatory affairs Melinda Plaisier says that the Office of Regulatory Affairs has named a new ombudsman to help stakeholders with unresolved concerns. Writing in an FDA Voice blog post, Plaisier says that ombudsman Jessica Zeller “is dedicated solely to helping you with assessing and resolving problems.
Devices
FDA has cleared an NEC Display Solutions of America 510(k) for the MultiSync MD211G5 medical-grade monitor for use in tomosynthesis applications and full field digital mammography. With a 21-inch display, the five-megapixel, grayscale monitor, which also has been cleared for standard mammography, “offers out-of-the-
Biologics
FDA has issued new guidance recommendations to reduce the potential transmission risk of Zika virus from human cells, tissues, and cellular and tissue-based products (HCT/Ps). The guidance addresses donation of HCT/Ps from both living and deceased donors, including donors of umbilical cord blood, placenta, or other gestational
Drugs
FDA has approved a Gilead Sciences NDA Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg) for treating HIV-1 infection in certain patients. Emtricitabine and tenofovir alafenamide are made by Gilead Sciences, and rilpivirine made by Janssen Sciences Ireland UC. Odefsey is indicated as a complete regimen
FDA Policy/General
Federal Register Notice: FDA is making available a draft document entitled Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Draft Guidance for Industry. It provides members of the medical and scientific community and other
FDA Policy/General
David Romeo, principal of a series of dietary ingredient companies in New Jersey has pleaded guilty in connection with the sale of methamphetamine precursor chemicals, a separate scheme to defraud purchasers of dietary supplements and money laundering. “The Department of Justice has increased its enforcement efforts against unlawful dietary supplements
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Glaxo’s Anoro Ellipta (umeclidinium/vilanterol) is 1,589 days for extending a patent which claims the human drug product. It is indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive
FDA Policy/General
Federal Register Proposed rule: FDA is proposing to classify the blood establishment computer software (BECS) and BECS accessories into Class 2 (special controls). The agency is also giving notice that the it does not intend to exempt BECS and BECS accessories from premarket notification requirements of the the FD&
Drugs
FDA has delayed a review action on a Heron Therapeutics NDA resubmission for Sustol (granisetron) extended release injection, indicated for preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) regimens. The original user fee goal date was 1/
Biologics
FDA has accepted for review a Genentech supplemental BLA for an expanded indication for Xolair (omalizumab) in pediatric patients with allergic asthma. The review will evaluate Xolair’s use in children aged six through 11 years for treating moderate to severe persistent asthma in those patients with a positive skin
FDA Policy/General
Federal Register Notice: FDA seeks public comment on research entitled “National Direct-to-Consumer Advertising Survey.” Its objective is to survey the public about their experiences with and attitudes toward direct-to-consumer advertising of prescription drugs. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a guidance for industry entitled Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act — Compliance Policy. It describes the agency’s compliance policy on certain requirements in the FD&C Act for trading partners
Drugs
With apologies for missing our deadline on last week’s report about a Warning Letter that took almost 14 months to be issued to Myerlee Pharmacy, Fort Myers, FL, FDA’s Office of Media Affairs 2/29 obliquely provided an indirect explanation that accepted no responsibility for the shock the
FDA Policy/General
A Western Texas jury has found Vascular Solutions and its CEO Howard Root not guilty on all federal charges concerning alleged off-label promotions of the Vari-Lase Short Kit. Senior U.S. District judge Royce Lamberth has entered an order dismissing the case that is final and not subject
Devices
Abbott has begun a Class 1 recall of its MitraClip Delivery System to reinforce the proper procedures used to operate and deploy the device. The company says it has received nine Medical Device Reports where the user was unable to separate the implantable Clip from the delivery system. “Abbott’s