Drugs
CDER has posted a Manual of Policies and Procedures updated policy on Drug Shortage Management. The manual establishes the Center’s policy and procedures for notification, evaluation, and management of drug shortage situations for all CDER products. It also outlines the responsibilities of the CDER drug shortage staff that are
Devices
FDA has cleared a Meridian Bioscience de novo submission for a new diagnostic test to aid in detecting a type of herpes virus called cytomegalovirus (CMV) in newborns less than 21 days of age. “The Alethia CMV Assay Test System is used as an aid in the diagnosis of congenital
Drugs
A new Government Accountability Office (GAO) report recommends that FDA ensure that information from orphan drug designation applications is consistently recorded in Office of Orphan Products Development (OOPD) review templates and evaluated by OOPD reviewers when making orphan designation decisions. The GAO review found that the agency does not consistently
FDA Policy/General
Federal Register notice: FDA has announced a 1/11/2019 joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee. The committees will discuss a Takeda Pharmaceuticals supplemental NDA for Uloric (febuxostat) tablets that includes the results from a postmarketing safety trial required by FDA
Devices
FDA has issued two draft guidances on blood glucose monitors used in home and healthcare settings. When finalized, the guidances will replace those issued in 2016 to provide more clarification on design considerations and recommended standards as requested by stakeholders. The first draft, Blood Glucose Monitoring Test Systems for Prescription
FDA Policy/General
Federal Register notice: FDA has issued 22 new and 41 revised product-specific guidances that when finalized will describe the agency’s thinking and expectations on how to develop generic drugs that are therapeutically equivalent to their respective reference-listed drugs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies.” The document describes study designs for generating data that support both 510(k) clearance and CLIA waiver. FDA says that using the dual use
FDA Policy/General
Federal Register notice: FDA has announced a 1/17/2019 Endocrinologic and Metabolic Drugs Advisory Committee meeting. Panel members are scheduled to discuss a Sanofi-Aventis NDA for sotagliflozin, indicated as an adjunct to insulin therapy to improve glycemic control in adults with Type 1 diabetes mellitus. To view the
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” The document represents FDA’s current thinking on the appropriate use of comparable performance between a waived user and
Drugs
FDA has issued a drug safety alert to warn about rare but serious cases of stroke and tears in the lining of arteries in the head and neck that have occurred in patients with multiple sclerosis shortly after they received Genzyme’s Lemtrada (alemtuzumab). “As a result, we have added
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” The document represents FDA’s current thinking on the appropriate use of comparable performance between a waived user and
Drugs
FDA is warning that signs and symptoms of a life-threatening side effect called “differentiation syndrome” are not being identified in patients receiving Celgene’s acute myeloid leukemia drug Idhifa (enasidenib). A safety alert notes that the drug’s prescribing information and patient Medication Guide already contain a warning about
Drugs
The European Medicines Agency (EMA) says that FDA has confirmed the capability of Belgium, Denmark, Estonia, Finland, and Latvia and now has 20 EMA member states it can rely on to replace agency inspections. “Imported products still need to be batch tested until FDA recognizes all EU member states’ authorities
Drugs
Janssen says an FDA draft guidance on adaptive designs for clinical trials of drugs and biologics “provides clear expectations for planning and implementation of adaptive designs in clinical trials.” The company says it believes the guidance will facilitate wider use of the innovative and more efficient designs in drug development.
Drugs
FDA commissioner Scott Gottlieb says failures in policy and economics over many years are responsible for the current increase in drug shortages. Speaking 11/27 at a Duke University Margolis Center for Health Policy conference on “Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions,” Gottlieb described agency
Drugs
FDA has issued 22 new and 41 revised product-specific guidances that when finalized will describe the agency’s thinking and expectations on how to develop generic drugs that are therapeutically equivalent to their respective reference-listed drugs. The agency says that since 2007 it has issued more than 1,
Drugs
A 6/22-6/27 FDA inspection at Corona Doctors Medical Clinics, Corona, CA, found objectionable conditions in the clinic’s role as the sponsor of a redacted clinical investigation. An 11/16 Warning Letter says the inspection was conducted as a part of FDA’s Bioresearch Monitoring Program. Specific
Devices
FDA has approved an Ortho Clinical Diagnostics expanded indication for its Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator for use on Ortho’s Vitros ECi/ECiQ Immunodiagnostic Systems. The HIV combo test was previously approved for use on Ortho’s Vitros 5600 Integrated System and Ortho’s Vitros
Devices
FDA has cleared an electroCore 510(k) for an expanded label for gammaCore vagus nerve stimulator therapy for adjunctive use for preventing cluster headaches in adult patients. The clearance was supported by data from two studies, including PREVA (PREVention and Acute treatment of chronic cluster headache), a prospective, open-label,
Devices
FDA has published a draft guidance, Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices, to implement a section of the 21st Century Cures Act requiring the agency to revise Section V, “Demonstrating Insignificant Risk of Erroneous Result—
Drugs
Teva Pharmaceuticals has recalled all lots of amlodipine/valsartan combination tablets and amlodipine/valsartan/hydrochlorothiazide combination tablets due to an impurity detected above specification limits in an active pharmaceutical ingredient manufactured by Mylan India. The impurity found in Mylan’s valsartan API is identified as N-nitroso-diethylamine (NDEA), which
Drugs
The Justice Department says Alec Burlakoff, former Insys Therapeutics vice president for sales, has pleaded guilty in Massachusetts federal court to participating in a nationwide conspiracy to bribe medical practitioners to unnecessarily prescribe a fentanyl-based pain medication and defraud healthcare insurers. Burlakoff pleaded guilty to one count of racketeering