Drugs
FDA has released a guidance entitled “Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency.” The document addresses the limited number of drugs that are subject to a REMS that requires laboratory testing ( e.g., liver enzyme testing) or imaging studies (e.g., magnetic resonance imaging). FDA
FDA Policy/General
DRUGS FDA has granted accelerated approval to Merck’s Keytruda (pembrolizumab) for treating patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test. The expanded approval is intended for patients experiencing disease progression on or after
FDA Policy/General
Clinical-stage oncology company ProNAi Therapeutics has obtained an exclusive license from CarnaBiosciences, Kobe, Japan, for worldwide rights to develop and commercialize AS-141, a small molecule kinase inhibitor targeting CDC7. According to the companies, ProNAi will pay Carna Biosciences an initial upfront payment of $0.9 million and additional
FDA Policy/General
Federal Register notice: FDA has permanently debarred Stephen Kalinoski from providing services in any capacity to a person that has an approved or pending drug product application. Kalinoski previously worked at medical drug repackager Med Prep Consulting. He was convicted of a felony for introducing adulterated and misbranded drugs into
FDA Policy/General
Federal Register notice: FDA has permanently debarred Gerald Tighe from providing services related to an approved or pending drug product application. Tighe was the owner of Med Prep Consulting, a medical drug repackager in New Jersey, and conspired with others to introduce adulterated and misbranded drugs into interstate commerce. To
FDA Policy/General
Federal Register notice: FDA has permanently debarred Brenda Elise Edwards from providing services in any capacity to a person that has an approved or pending drug product application due to a felony conviction. Edwards previously was a Cumberland Distribution employee and engaged in wholesale prescription drug distribution. Cumberland purchased millions
Drugs
FDA has issued two guidance documents to communicate its policy for temporary manufacturing of certain alcohol-based hand sanitizer products. Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) is immediately in effect and outlines that the agency does not intend
Devices
FDA has issued a new policy that allows manufacturers of certain FDA-cleared vital sign-measuring devices to expand their use for healthcare providers to monitor patients remotely. The devices include those that measure body temperature, respiratory rate, heart rate and blood pressure. “This policy applies to certain modifications to
Drugs
FDA has issued a guidance entitled “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic.” The document discusses situations where medical product adverse event reports could be delayed due to pandemic-related high employee absenteeism. The document says that certain required submissions could be delayed provided
Drugs
Based on media reports that certain painkillers may worsen coronavirus disease (COVID-19), a new FDA safety update says the agency is not aware of scientific evidence connecting the use of NSAIDs, like ibuprofen, with any worsening symptoms. The news reports came after a 3/11 letter in The Lancet
Drugs
FDA has issued Boehringer Ingelheim and Eli Lilly a complete response letter on a supplemental NDA New Drug Application (sNDA) for empagliflozin 2.5 mg and its use as an adjunct to insulin for adults with Type 1 diabetes. The letter states that the agency is unable to approve the
FDA Policy/General
FDA Permanently Debars Kalinoski on ‘Filthy’ Drugs Federal Register notice: FDA permanently debars Stephen Kalinoski from providing services in any capacity to a person that has an approved or pending drug product application. 03/20/2020 Tighe Permanently Debarred by FDA Federal Register notice: FDA permanently debars Gerald Tighe from
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide.” The document discusses new required health warnings for cigarette packages and advertisements. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has issued a final rule to establish new health warnings for cigarette packages and advertisements. The final rule implements a provision of the Family Smoking Prevention and Tobacco Control Act that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking
FDA Policy/General
Federal Register notice: FDA has reopened the comment period for a 6/1/2018 notice entitled “Development of a Shared System Risk Evaluation and Mitigation Strategy; Draft Guidance for Industry; Availability.” Comments should be submitted by 5/18. To view the notice, click here.
FDA Policy/General
Federal Register notice: CDER has listed certain meetings from 3/10 through 4/30 that are postponed, canceled, or modified to take place remotely. If a meeting is rescheduled, information about the rescheduled meeting will be provided in the future. To view the notice, click here.
Devices
Unable to require medical device manufacturers to report shortages, FDA is turning to Twitter to hunt for information on coronavirus testing supplies. Politico reports that a “fundamental gap in the flow of information has made it impossible for FDA to identify weaknesses in the supply chain for coronavirus testing and
Drugs
FDA says it has approved changes to the labeling for Gilead’s Epclusa (sofosbuvir and velpatasvir) to provide for use in pediatric patients with chronic hepatitis C virus (HCV) ages six years and older or weighing at least 37 pounds with any of the six HCV genotypes without cirrhosis or
Drugs
Stakeholders are asking FDA to consider making changes to a draft guidance on demonstrating substantial evidence of effectiveness for human drug and biological products. The Biotechnology Innovation Organization says that the agency should combine the draft with existing guidance on effectiveness. It also says the guidance (1) should more clearly
Drugs
FDA commissioner Stephen Hahn says that FDA is looking at repurposing older drugs to treat or prevent coronavirus. During a 3/19 White House press briefing, Hahn said one drug of interest is the decades-old malaria drug chloroquine, which is made by several manufacturers, and its potential expanded use
Biologics
A 3/25-4/3/19 FDA inspection at Invitrx Therapeutics, Lake Forest, CA, documented 17 issues in the firm’s processing of products for allogeneic use. A 3/16 Warning Letter lists 17 significant deviations from current good manufacturing practice (CGMP) regulations applicable to the firm’s products as
Drugs
Mallinckrodt has completed a rolling NDA submission for terlipressin, an investigational agent being evaluated for treating hepatorenal syndrome Type 1 (HRS-1). HRS-1 is a life-threatening condition involving acute kidney failure in people with cirrhosis. In 2016, Mallinckrodt and the agency reached agreement on the Phase 3 CONFIRM