Devices
Sen. Patty Murray (D-WA) has introduced the Preventing Superbugs and Protecting Patients Act to give FDA additional tools to review and ensure the safety of medical devices and contaminated duodenoscopes that were linked to life-threatening antibiotic-resistant infections. Murray says an investigation she led showed that manufacturers of
Drugs
The BMJ (formerly the British Medical Journal) says that doctors and scientists are saying that there should be an independent investigation into the Duke Clinical Research Institute ROCKET-AF trial supervised by FDA commissioner-nominee Robert Califf that was used to support Bayer’s Xarelto (rivaroxaban). The blood thinner, marketed
FDA Policy/General
FDA says that in Fiscal Year 2015 it had one product seizure, 21 injunctions, 17,232 Warning Letters, 2,789 recall events, 9,178 recalled products, and 14 drug product debarments. The agency’s summary of enforcement statistics breaks down each of those categories. It shows, for instance, that seizures
Drugs
FDA acting commissioner Stephen Ostroff says that after several years of building a modern generic drug review process, the agency is on track to achieve the kind of success the Generic Drug User Fee Amendments (GDUFA) envisioned. Writing in an FDA Voice blog post, Ostroff says that the agency is
Drugs
Patterson Belknap attorneys say that a number of court decisions since the 2010 enactment of the Biologics Price Competition and Innovation Act (BPCIA) have laid out the basic framework for implementation of the act, at least until the next series of disputes is litigated. Writing in an online post, the
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products,” 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’s collection of information entitled “Postmarketing Adverse Drug Experience Reporting” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA’s collection of information entitled “Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application,” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled List of Highest Priority Devices for Human Factors Review. The agency aims to inform medical device manufacturers on which device types should have human factors data included in premarket submissions. FDA believes these device types have clear potential for
FDA Policy/General
Federal Register Notice: FDA makes available a draft guidance for industry and FDA staff entitled Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices. It will describe the agency’s intent not to enforce, before 9/24/21, the prohibition against providing National
Drugs
GlaxoSmithKline and Adaptimmune Therapeutics have expanded the terms of their strategic collaboration agreement to accelerate Adaptimmune’s lead clinical cancer program, an affinity enhanced T-cell immunotherapy (GSK3377794) targeting NY-ESO-1 toward pivotal trials in synovial sarcoma. The collaboration and licensing agreement was announced in 6/2014. “At GSK
FDA Policy/General
Three Kaye Scholer attorneys say that FDA regulatory experts often testify in court cases and can serve a valuable purpose in helping juries understand regulations and how companies interact with the agency. Writing in an online post, the three say that sometimes parties, often plaintiffs, try to use regulatory experts
Drugs
Depomed is petitioning FDA to delay granting final approval to ANDAs citing Nucynta ER (tapentadol) as the reference-listed drug until the sponsors submit a revised patent certification for the ’130 patent as it is currently listed in the Orange Book. The petition calls on the agency to delay granting
FDA Policy/General
Federal Register Notice: FDA’s collection of information entitled “Biosimilar User Fee Cover Sheet; Form FDA 3792,” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled Applying Human Factors and Usability Engineering to Medical Devices. Its purpose is to assist industry in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended
Drugs
Public Citizen says that demonstrators will gather 2/4 at 12 noon outside the Washington, DC, headquarters of Pharmaceutical Research and Manufacturers of America to protest the drug industry’s support for the Trans-Pacific Partnership (TPP) expansion of medicine monopolies. The advocacy group says that demonstrators will wear surgical
Drugs
FDA has approved a Dr. Reddy’s Laboratories NDA for Zembrace SymTouch (sumatriptan succinate) injection, a drug-device combination product (autoinjector) intended for treating acute migraine episodes, with or without aura, in adults who are inadequately managed with existing treatment regimens. The product is available as a prefilled, ready-to-
Devices
An Oklahoma federal court ruled 1/28 that a suit against Boston Scientific over a Class 3 spinal cord stimulator was expressly preempted under provisions of the Medical Device Amendments of 1976. Attorney Michelle Yeary (Dechert) writes in an online post that the court found that the plaintiff’s allegations
Devices
At the 1/11 MDUFA 4 reauthorization patients and consumer stakeholder meeting, FDA reviewed the current status of a number of proposals and addressed clarifying questions from stakeholders. Meeting minutes indicate that the agency identified the places of commonality in proposals posed by it and industry such as with de
Drugs
An FDA-sponsored report by the Institute of Medicine recommends that the agency allow sponsors to conduct initial mitochondrial replacement technique (MRT) clinical investigations only when several conditions are met. These include limiting clinical investigations to women who are at risk of passing on a serious mitochondrial disease to their
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry and FDA staff entitled Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development. It provides guidance on the underlying principles of human factors studies during the development of combination products. To download this
Devices
FDA has cleared a Focal Healthcare 510(k) for its targeted prostate biopsy device, Fusion Bx. The device is intended to assist clinicians in taking targeted biopsies directly from suspicious cancer regions within the prostate using MRI-ultrasound “fusion” technology, according to the company. “MRI has the ability to see