FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. KVK-Tech, Newtown, PA (10/8): FDA inspected the firm in February and cited significant GMP violations for finished pharmaceuticals. For example, KVK-Tech failed to establish and follow
FDA Policy/General
Guide on Nicotine Delivery System Enforcement Federal Register notice: FDA makes available a final guidance entitled “Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (Revised).” 10/23/2020 Info Collection on Animal Drugs for Minor Species Federal Register notice: FDA
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product — Compliance Policies. The document explains that FDA intends to extend an ongoing delay in enforcement. To view the notice,
Drugs
The Western Virginia District Court has sentenced former Indivior CEO Shaun Thaxter to six months in federal prison after he pleaded guilty for his role in causing the introduction into interstate commerce misbranded shipments of the opioid drug Suboxone Film (buprenorphine). He was also ordered to pay a fine of
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded — Time and Extent Applications for Nonprescription Drug Products (21 CFR 330.14)” (OMB Control Number 0910–0688)
FDA Policy/General
Federal Register notice: FDA has made available an annual compilation of updates to the agency’s Susceptibility Test Interpretive Criteria Web page. The agency established the page in 2017, and subsequently it has provided updates to both the format of the Web pages and to the susceptibility test interpretive criteria
FDA Policy/General
HHS secretary Alex Azar reportedly has been expressing his unhappiness with FDA commissioner Stephen Hahn and is openly plotting his removal from office. In a lengthy online post, Politico says its anonymous sources, a half-dozen current and former administration officials, indicate that Azar has gone so far as to
FDA Policy/General
Federal Register notice: FDA has announced that it intends to conduct a fit-for-use pilot program to test the processing and analysis of nonclinical study data provided electronically for the Clinical Data Interchange Standards Consortium for Standard for Exchange of Nonclinical Data Implementation Guide: Developmental and Reproductive Toxicology v1.
FDA Policy/General
Federal Register notice: FDA has determined that 28 drug products listed in the notice were not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to continue to approve ANDAs that reference the products if they meet legal and regulatory requirements. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989. The reporting forms are intended to facilitate submissions by drug and biological product application holders of complete and accurate information
FDA Policy/General
Federal Register notice: FDA has issued an order debarring Keith Komar for five years from importing or offering for import any drug into the U.S. The order is based on Komar’s 2019 conviction for mail fraud for knowingly causing the U.S. mail to deliver from Mumbai, India,
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Medoz Pharmacy of Polk, Davenport, FL (9/25): FDA inspected the firm in August and cited serious deficiencies in its practices for producing sterile drug products. For example, the
FDA Policy/General
Spurred by the Covid-19 emergency, FDA says it is speeding up the implementation of a software-defined network and adoption of other design approaches that make the transition to cloud-based technologies faster and more secure. This work is spearheaded by the agency’s Technology Modernization Action Plan (TMAP)
FDA Policy/General
At the request of several Democrat senators, the Government Accountability Office (GAO) has agreed to conduct an investigation of the Trump Administration’s alleged political interference at FDA and the Centers for Disease Control and Prevention (CDC) to determine whether the interference has violated the agencies’ scientific integrity and communication
FDA Policy/General
Federal Register notice: FDA is announcing the Web site location where it will post two lists outlining guidance documents that CDRH intends to publish in fiscal year 2021. In addition, FDA has established a docket where interested parties may comment on the guidance topic priorities, provide comments or propose draft
FDA Policy/General
Federal Register notice: FDA is requesting that any industry organizations interested in participating in selecting nonvoting industry representatives to serve on certain Medical Devices Advisory Committee panels notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on certain device panels. To view the notice,
FDA Policy/General
Info Request on Combo Product Designations Federal Register notice: FDA seeks comments on an information collection extension related to its guidance entitled “Combination Products: How to Write a Pre-Request For Designation (RFD).” 10/16/2020 Modified Device Consensus Standards Listing Federal Register notice: FDA modifies the list of standards
FDA Policy/General
Federal Register notice: FDA has reopened the comment period for a 6/1 notice entitled “Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments.” Electronic or written comments can now be submitted by 11/16. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available three guidance documents related to the Covid–19 public health emergency. The guidances have been implemented without prior comment, but they remain subject to comment under the agency’s good guidance practices. They are: * Manufacturing, Supply Chain, and Drug and Biological Product Inspections
FDA Policy/General
Federal Register notice: FDA makes available a final guidance entitled Testing for Biotin Interference in In Vitro Diagnostic Devices. The document provides recommendations on testing for interference by biotin on the performance of in vitro diagnostic devices (IVDs). It is intended to help device developers and clinicians understand how the
FDA Policy/General
The northern Texas federal court has sentenced two former dietary supplement company executives to prison and ordered two companies to pay a combined $10.7 million in criminal forfeiture for their roles in fraudulently selling popular workout supplements. Former USPlabs CEO Jacobo Geissler (University Park, TX) was sentenced to 60
FDA Policy/General
FDA is evaluating whether it can use live or recorded video to conduct medical product inspections as the Covid-19 pandemic continues to disrupt the agency in its inspection duties. Early in the pandemic, FDA suspended both domestic and foreign inspections, and in late July domestic inspections resumed on a