Drugs
HHS has issued a new rule and the National Institutes of Health (NIH) has issued a new policy, both of them intended to increase the availability of clinical trial information and data on clinicaltrials.gov, which is run by NIH. The final rule applies to “responsible parties,” a clinical trial
Drugs
FDA is working with stakeholders to revisit criteria used for determining whether a patient is eligible to participate in a trial, according to Oncology Center of Excellence (OCE) acting director Richard Pazdur in a new blog posting. “Modifying the eligibility criteria could expand the number of people who qualify and
FDA Policy/General
Federal Register Notice: FDA is seeking comments on a proposed collection of information related to the agency’s Unique Device Identification (UDI) System. Comments are sought on requirements for medical device labelers to include an expiration date, a date of manufacture, or any other date intended to be brought to
FDA Policy/General
Federal Register Notice: FDA is making available a guidance on “Qualification of Biomarker — Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease.” The document provides a qualified context of use for total kidney volume, measured at baseline, to be used as a prognostic enrichment biomarker to
FDA Policy/General
Federal Register Notice: FDA has released a guidance on “Recommendations for Microbial Vectors Used for Gene Therapy” that provides recommendations concerning IND submissions for microbial vectors used for gene therapy in early phase clinical trials. The guidance focuses on the chemistry, manufacturing, and control information that sponsors should submit in
FDA Policy/General
Federal Register Notice: FDA has made available a revised guidance for industry (#171) on “Waivers from the Requirement to Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles.” The document describes how CVM intends to evaluate requests for waiving the requirement for
FDA Policy/General
Federal Register Notice: FDA has planned a public workshop on “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices (ASTs). It is intended to facilitate discussion between drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs or ASTs and who wish to coordinate development of
FDA Policy/General
Federal Register Notice: FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation have planned a three-day (11/7-9) training course for clinical investigators. It is intended to provide expertise in the design, conduct, and analysis of clinical trials; to improve the quality of
Devices
FDA has approved an Acclarent de novo petition to permit marketing of the Aera Eustachian Tube Balloon Dilation System for treating persistent eustachian tube dysfunction (ETD), a condition in which pressure, pain or clogged or muffled sensations occur in the ear. The device allows a physician to use a catheter
Drugs
Metabolic Therapy Inc. has filed a petition asking FDA to amend the Over-the Counter Acne Drug Products monograph for active ingredients to indicate that chromium is safe and effective for acne treatment. The petition says that when glucose levels and insulin levels rise, the liver responds to the higher
FDA Policy/General
Drug company digital and non-personal contacts are on the rise as sales representatives are denied access to physicians, according to new reports from ZA Associates. In fact, such activities have now exceeded the number of sales rep visits to doctor offices, the reports say. According to AccessMonitor, the number
Devices
FDA has approved a Medtronic PMA for the IN.PACT Admiral drug-coated balloon for treating in-stent restenosis in patients with peripheral artery disease. This is the first drug-coated balloon approved to treat in-stent restenosis in the U.S. Approval was based on data from the IN.
Drugs
Members of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 10-9 on 9/14 to recommend that FDA remove a Boxed Warning from labeling for Pfizer’s smoking-cessation drug Chantix (varenicline). The Boxed Warning contains statements about the risk of serious
Drugs
FDA has published a guidance, Qualification of Biomarker—Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients with Chronic Obstructive Pulmonary Disease, to provide a qualified context of use for the biomarker plasma fibrinogen in interventional clinical trials of patients with chronic obstructive pulmonary disease at
Drugs
Sens. Tammy Baldwin (D-WI) and John McCain (R-AZ) and Rep. Jan Schakowsky (R-IL) have introduced the FAIR Drug Pricing Act as “the first step in addressing skyrocketing prescription drug prices by requiring transparency for pharmaceutical corporations that plan to increase drug prices.” A statement issued by Sen.
Drugs
FDA has approved an Aralez Pharmaceuticals NDA resubmission for Yosprala (aspirin and omeprazole), indicated for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers. “Secondary prevention with aspirin may be recommended in patients who have had a myocardial infarction or unstable angina pectoris, chronic
Drugs
FDA has extended by three months its review of a Lexicon Pharmaceuticals NDA for telotristat etiprate, an oral drug for treating carcinoid syndrome. In response to an information request from the agency, additional clinical data analyses have been submitted and the extension will provide additional time to review it. The
Drugs
Virtus Pharmaceuticals has recalled seven batches of hyoscyamine sulfate (0.125mg) due to both superpotent and subpotent test results. All of the affected batches were manufactured by Pharmatech LLC for distribution by Virtus throughout the U.S. and Puerto Rico. See a press release for a listing of affected batch
Drugs
According to a just-released FDA summary, patients with Alpha-1 Antitrypsin Deficiency (AATD) said at a 9/29/15 FDA public meeting that while significant treatment advances have occurred, much remains to be done and they would like to see a cure, through gene therapy or a lung or
Devices
Varian Medical Systems has received 510(k) clearance to market the Nexus DR, a high resolution system for X-ray imaging using a digital X-ray detector. The device is designed to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications, according to the company. The
Drugs
FDA has released a guidance on “Qualification of Biomarker Total Kidney Volume (TKV) in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease” that provides a qualified context of use (COU) for the biomarker TKV in such studies. The document also describes the experimental conditions and constraints for which this
FDA Policy/General
Brown University researchers say that while little has been learned over the years about the effect of direct-to-consumer advertising on psychiatric conditions, it appears that the ads succeed in driving prescribing with potentially mixed effects on patient care. Writing in the Journal of Clinical Psychiatry, the researchers say