FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for Regeneron Pharmaceuticals’ Kevzara (sarilumab), indicated for treating adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs. The regulatory
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for Provepharm’s Provayblue (methylene blue), indicated for treating pediatric and adult patients with acquired methemoglobinemia. The regulatory review period has been determined to be 415 days, which includes 232 days that occurred during the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled: “Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring — 21 CFR Parts 312 and 812” (OMB Control Number 0910-0733). The information collection supports reporting and recordkeeping found in agency guidance. Under 21 CFR parts 312
FDA Policy/General
Draft Guide on Blood Glucose Monitoring 510(k)s Federal Register notice: FDA makes available a draft guidance entitled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.” 11/30/2018 Draft Guide on OTC Blood Glucose Monitors Federal Register notice: FDA makes available a draft guidance entitled
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.” The document describes studies and criteria that FDA recommends be used when submitting 510(k)s for blood glucose monitoring systems that are for prescription point-of-care
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.” The document describes studies and information that the agency recommends be used when submitting 510(k)s for self-monitoring blood glucose test systems that are for over-
FDA Policy/General
Federal Register notice: FDA has announced a 1/16 Bone, Reproductive and Urologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss an Amgen BLA for romosozumab injection, indicated for treating osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple
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
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
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
FDA Policy/General
Federal Register notice: FDA has announced a 4/10/2019 public meeting entitled “Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.” The meeting and comment opportunity is intended to fulfill FDA’s commitment to seek stakeholder input on data standards and the electronic submission system’s
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. The Delano Co., dba LifeLink Grover Beach, CA (9/7): FDA inspected the firm in April, and after a subsequent review of product labels and statements contained on company
FDA Policy/General
Info Collection on Drug Labeling Content/Format Federal Register notice: FDA submits to OMB an information collection extension entitled “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products.” 11/21/2018 Teva Used Priority Voucher for Migraine Drug Federal Register notice: FDA announces an approval
FDA Policy/General
Federal Register notice: FDA has announced an approval for Teva’s Ajovy (fremanezumab-vfrm) injection for preventing migraine in adults under a redeemed priority review voucher. Such vouchers are awarded to sponsors of approved rare pediatric disease product applications that meet certain criteria. The agency is required to publish notice
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products,” (OMB Control Number 0910–0572). To view the notice, click here.
FDA Policy/General
The FDA Webview newsroom is closed in observance of the Thanksgiving Day holiday in the U.S. It will reopen on Monday, November 26 and the next overnight email bulletin will be sent that night, dated November 27.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection entitled “Survey of Current Manufacturing Practices for the Cosmetics Industry.” The agency defines cosmetics as articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed framework for regulating software applications disseminated by or on behalf of drug sponsors for use with one or more of their prescription drug products. The proposed framework would provide prescription drug sponsors the flexibility to develop and disseminate innovative software,
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. American Contract Systems Bloomington, MN (11/6): FDA inspected the firm’s medical device operations in October and cited GMP deficiencies. For example, the firm failed to adequately validate