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Federal Register Notice: FDA is making available a draft guidance for industry and FDA staff entitled Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.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
Biologics
FDA has granted TapImmune a fast track designation for its cancer vaccine TPIV 200 and its use in treating ovarian cancer. The designation covers the use of multiple-epitope folate receptor alpha peptide vaccine (TPIV 200) with GM-CSF adjuvant for maintenance therapy in subjects with platinum-sensitive advanced ovarian
Drugs
FDA has granted Conatus Pharmaceuticals a fast track designation for emricasan and its development program for treating liver cirrhosis caused by nonalcoholic steatohepatitis (NASH). “The data from our recently completed Portal Hypertension trial, showing clinically meaningful reductions in hepatic venous pressure gradient (HVPG) in patients with severe portal hypertension after
Biologics
FDA has issued Telesta Therapeutics a complete response letter on its BLA for MCNA (Mycobacterium phlei cell wall-nucleic acid complex), indicated for treating high risk non-muscle invasive bladder cancer patients who have failed front line Bacillus Calmette-Guerin therapy. The agency’s letter indicated that an additional Phase
Devices
FDA has issued two guidances dealing with human factors in medical devices. The first, a draft guidance, List of High Priority Devices for Human Factors Review, is to inform medical device manufacturers which device types should have human factors data included in premarket submissions. The document says that the agency
FDA Policy/General
Federal Register Notice: CBER is inviting biologics facilities to contact the Center for more information on participating in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities to allow CBER staff
FDA Policy/General
Federal Register Notice: FDA’s collection of information entitled “General Licensing Provisions; Section 351(k) Biosimilar Applications” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.
Drugs
A 2/1 Congressional briefing by the Generic Pharmaceutical Association (GPhA) concluded that generic drug prices are not an important part of the drug cost problem facing the nation. The group reiterated findings from a recent HHS brief on Understanding Recent Trends in Generic Drug Prices, which revealed that about
Devices
FDA has issued a draft guidance, Enforcement Policy of National Health Related Item Code and National Drug Code Numbers Assigned to Devices, describing the agency’s intent not to enforce before 9/24/21 the prohibition against providing National Health Related Item Code or National Drug Code numbers on device
Drugs
FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) 2/3 will discuss whether cognitive impairment in major depressive disorder (MDD) is a suitable target for drug development, and if so, how it should be studied. Briefing materials released in advance of the meeting note that, historically, CDER’s Division of Psychiatry
Drugs
Cancer patients who attend FDA advisory committee meetings and address the panel during open comment periods often have financial ties with the company seeking marketing approval, and those ties aren’t always disclosed, according to an analysis appearing in JAMA Internal Medicine. “The industry has hijacked that microphone – they’re
FDA Policy/General
Positive feelings produced by images in direct-to-consumer drug ads can promote favorable beliefs about the drugs, according to research published online in Bioethical Inquiry (subscription or purchase required). Researchers from the U.S. and Australia say that their work shows that pairing a hypothetical influenza prescription medicine with
Drugs
A 6/3-6/24/15 FDA inspection at the Kirkman Laboratories drug manufacturing facility in Lake Oswego, OR, found that the company is marketing four unapproved new drugs, according to a 1/13 Warning Letter from the agency’s Seattle District Office. The document lists both unapproved new drug
Drugs
U.S. Representatives G. K. Butterfield (D-NC) and Susan Brooks (R-IN) have introduced HR 4400, a bipartisan bill that seeks to add Zika virus to the list of diseases included in FDA’s Tropical Disease Priority Review Voucher Program. The voucher program was enacted in 2007 to incentivize
Devices
Booz Allen Hamilton says that its evaluation of CDRH’s progress in implementing the consulting firm’s recommendations for improving the review of medical device premarket submissions shows that the Center successfully completed Stage 1 for each project in its Plan of Action to address the consulting firm’s recommendations.
Drugs
Yale Law School professor Amy Kapczynski says that a federal court decision in a suit brought by Amarin against FDA over dissemination of off-label information on its Vascepa in effect replaces drug regulators with judges, whose expertise in science and medical research varies considerably, when off-label promotion is
FDA Policy/General
Federal Register Notice: FDA seeks comments on the reporting requirements for submission and listing of patent information associated with a new drug application, an amendment, or a supplement. Comments should be submitted by 4/4. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA’s collection of information entitled “Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.