Drugs
FDA and the Federal Trade Commission have posted joint Warning Letters to the marketers and distributors of 12 opioid cessation products. The letters say the companies are illegally marketing unapproved products with claims about their ability to help treat opioid addiction and withdrawal. An FDA statement says the products have
FDA Policy/General
Federal Register notice: FDA has announced a 3/22 joint Pediatric Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee meeting which is expected to discuss the major objectives of a Phase 3 drug development program indicated for treating children with achondroplasia. Study elements to be considered include : Evidence required
FDA Policy/General
Federal Register notice: FDA has announced a timetable for updates to the FDA Data Standards Catalog for study data submitted electronically in NDAs, ANDAs, BLAs and certain INDs. The initial implementation timetable for submitting standardized study data in electronic format was 24 months for NDAs, ANDAs, and applications, and 36
FDA Policy/General
Attorney Mark Senak (FleishmanHillard) says that while the number of FDA news releases has remained generally consistent over the last few years, changes in substance and style reflect differences between commissioner Scott Gottlieb and former commissioner Robert Califf. Writing in his Eye on FDA blog, Senak says that the agency
FDA Policy/General
Federal Register notice: FDA has extended the comment period on a draft guidance entitled “The Least Burdensome Provisions: Concept and Principles.” Comments now can be submitted until 3/15. To view the notice, click here.
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says that a Web page and brochure issued by UCLA on the investigational new drug Gallium-68 (Ga68-PSMA) are suggesting in a promotional context that the drug is safe and effective for the purpose for which it is being investigated, or
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Millennium Pharmaceuticals’ Ninlaro (ixazomib) was 2,538 days. Of this time, 2,404 days occurred during the testing phase and 134 days occurred during the approval phase. The product is indicated for use in
FDA Policy/General
The U.S. Senate has reached an agreement to pass a continuing resolution that will end the current three-day government shutdown. Due to a heavy reliance on industry-paid user fees, FDA was able to keep 58% (10,050 staff) on the job Monday, according to an HHS contingency
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Sorin Group Italia’s Perceval Sutureless Heart Valve was 1,003 days. Of this time, 694 days occurred during the testing phase and 309 days occurred during the approval phase. The product is indicated
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Ardea Biosciences’ Zurampic (lesinurad) was 2,245 days. Of this time, 1,886 days occurred during the testing phase and 359 days occurred during the approval phase. The product is indicated in combination with
FDA Policy/General
Draft Guide on Expedited Notifications on Product Recalls Federal Register notice: FDA makes available a draft guidance entitled “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C.” 01/19/2018 Draft Guide on Medical Countermeasure Voucher Program Federal Register notice: FDA makes available a draft guidance
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C.” The document outlines the agency’s intent to increase and expedite public warnings and public notifications about violative products being recalled. It also clarifies and supplements
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Material Threat Medical Countermeasure Priority Review Vouchers.” The guidance addresses a provision in the 21st Century Cures Act that adds a new section to the federal Food, Drug, and Cosmetic Act on priority review vouchers for material threat medical
FDA Policy/General
As the threat of a government shutdown grows stronger due to a fiscal year 2018 budget impasse, a revised HHS contingency staffing plan reveals a higher number of FDA staff would stay on the job than earlier estimated (see earlier story). The contingency plan details that 58% (10,050 staff)
FDA Policy/General
Federal Register notice: FDA has permanently debarred William Ralph Kincaid from providing services in any capacity to a person that has an approved or pending drug product application. The debarment is based on Kincaid’s felony conviction in 2013 after pleading guilty to receiving in interstate commerce a misbranded drug
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Forest Laboratories’ Avycaz (ceftazidime pentahydrate and avibactam sodium) was 2,579 days. Of this time, 2,333 days occurred during the testing phase and 246 days occurred during the approval phase. The product is
FDA Policy/General
FDA has issued a draft guidance, Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C, to assist and provide recommendations about the use, content, and circumstances for issuing public warnings and public notifications for firm-initiated or FDA-requested recalls under 21 CFR Part 7, Subpart
FDA Policy/General
The Senate Finance Committee voted 15-12 to recommend to the full Senate the nomination of Alex Azar as HHS secretary, succeeding Tom Price, who was forced to resign after reports that he routinely flew in chartered jets at taxpayer expense. Observers believe Azar will win the nomination in the
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 22 ANDAs from multiple applicants. The holders of the applications notified the agency that the drug products were no longer marketed and requested that their approval be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register proposed rule: FDA has proposed to implement regulations regarding internal agency supervisory review of certain decisions related to devices regulated by CDRH. FDA is taking this action to codify the procedures and timeframes for supervisory review of significant decisions pertaining to devices within CDRH. FDA is also proposing
FDA Policy/General
Federal Register notice: FDA has submitted for OMB clearance a new information collection entitled “Use of Public Human Genetic Variant Databases To Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics — OMB Control Number 0910.” The information collection supports a similarly titled guidance document that describes the agency’
Drugs
FDA says promotional materials for a number of compounded drug products — Dropless products, LessDrops products, Simple Drops products, and Klarity C-Drops product — marketed by Imprimis Pharmaceuticals, San Diego, CA, make many false or misleading claims. The claims establish that the products are drugs, according to a 12/21/17