FDA Policy/General
The central Utah federal court has entered two consent decrees of permanent injunction against Evig LLC and Premium Production LLC, both of St. George, UT, over their distribution and marketing of Balance of Nature products. An FDA release says the products are marketed as dietary supplements, but their labeling “rendered
FDA Policy/General
Federal Register notice: FDA is renewing the Nonprescription Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 8/27/2025. To view the notice, click here.
FDA Policy/General
Law firm Cooley has added 14-year FDA veteran Son Nguyen to the firm’s Washington, DC office. At the agency, he most recently served as senior counsel in the Office of the Chief Counsel where he handled matters involving devices and combination products. Previously, Nguyen was FDA associate chief
FDA Policy/General
Federal Register notice: FDA is announcing an 11/29 Medical Devices Advisory Committee — Molecular and Clinical Genetics Panel meeting. Panel members are scheduled to discuss and make recommendations on the design of multi-cancer detection in vitro diagnostic devices as well as potential study designs and study outcomes of interest
FDA Policy/General
Federal Register notice: FDA has determined that Akorn’s Cogentin (benztropine mesylate) Injection (1 mg/1 mL) was not withdrawn due to safety or effectiveness reasons. The determination allows FDA to continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. Cogentin
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says an Evofem Biosciences direct-to-consumer brochure for its Phexxi (lactic acid, citric acid, and potassium bitartrate) vaginal gel overstates the expected benefits associated with using the product. A 10/31 Untitled Letter says the brochure makes false and misleading claims
FDA Policy/General
Federal Register notice: FDA is classifying the container system for the processing and storage of red blood cell components under reduced oxygen conditions into Class 2 (special controls). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a guidance entitled “Real-Time Oncology Review (RTOR).” The document provides recommendations to applicants on the process for submitting NDAs and BLAs with oncology indications for review under RTOR. The real-time review program facilitates earlier submission of topline results (i.e., efficacy
FDA Policy/General
Federal Register notice: FDA is making available a guidance entitled “Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing.” The document announces FDA’s intention to delay enforcement of requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the initial
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says an Otsuka direct-to-consumer TV ad and computer banner ad for Rexulti (brexpiprazole) tablets make false or misleading claims and representations about the drug’s efficacy. A 10/31 Untitled Letter says the violation is “especially concerning because major depressive
FDA Policy/General
Federal Register notice: FDA is proposing to withdraw approval of Phibro Animal Health’s NADAs for carbadox in medicated swine feed. This action is based on CVM’s determination that there is no approved regulatory method to detect carcinogenic residues in the edible tissues of treated swine. Carbadox is indicated
FDA Policy/General
Federal Register notice: FDA has determined that Novartis’ Foradil (formoterol fumarate) inhalation powder (.012 mg) was not withdrawn due to safety or effectiveness concerns. The determination will allow the agency to approve ANDAs referencing the product if all other legal and regulatory requirements are met. Foradil is indicated for treating
FDA Policy/General
Federal Register notice: FDA has identified certain Class 2 clinical electronic thermometers that, when this action is finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is requesting public comment on this action during a 60-day comment period and will consider whether any modifications should
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Enforcement Policy for Clinical Electronic Thermometers.” The document describes enforcement policies on certain legal requirements for clinical electronic thermometers, including those with and without telethermography or continuous temperature measurement functions. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions.” The document outlines FDA’s policies and regulatory review expectations after the Covid–19 public health emergency for certain limited modifications of a
FDA Policy/General
Republican members of the House Energy and Commerce Committee say they are “deeply concerned that FDA is not meeting important federal safety requirements to protect employees and the public while also failing to prioritize scientific data quality delivered from FDA laboratories.” In an 11/1 letter to FDA commissioner Robert
FDA Policy/General
Federal Register notice: FDA is announcing the renewal of its Patient Engagement Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 10/6/2025. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking interested industry organizations to participate in selecting nonvoting industry representatives to serve on certain CDRH panels of the Medical Devices Advisory Committee. The agency is also requesting nominations for nonvoting industry representatives to serve on the panels, and it notes that a nominee may
FDA Policy/General
Federal Register notice: FDA is issuing an order granting special termination of the debarment of David Winne, effective 8/28/2024. In August, Winne was permanently debarred from providing services related to an approved or pending drug product application. The debarment was based on Winne’s felony convictions as a
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Fresenius Kabi’s Omegaven (fish oil triglycerides) indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis. The regulatory review period for Omegaven is 4,246 days, of
FDA Policy/General
Federal Register notice: FDA has determined that 17 listed drug products were not withdrawn from sale for safety or efficacy reasons. The determination means that the agency will approve ANDAs that reference the drug products as long as they meet relevant legal and regulatory requirements. To view the notice, click
FDA Policy/General
Sarepta Therapeutics says it will file a supplemental BLA for Elevidys (delandistrogene moxeparvovec-rokl) to expand the therapy’s use in all patients with Duchenne muscular dystrophy (DMD). In June, FDA granted the gene therapy accelerated approval to treat pediatric patients aged four and five years of age who have