Drugs
FDA and the Federal Trade Commission say that the Web site www.organic-beauty-recipes.com is participating in the Amazon Associates program that pays the site owners a commission for promoting the sale of essential oil products. A 6/8 Warning Letter says the agencies’ review of the Web
Drugs
FDA has warned the owners of a Web site operating at chloroquineonline.com that they are offering drug products for sale in the U.S. that are intended to mitigate, prevent, treat, diagnose, or cure Covid-19. A 5/18 Warning Letter says such products are legally considered to be
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: chloroquineonline.com (5/18): FDA has warned the owners of chloroquineonline.com that they are offering drug products for sale in the
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency.” The document provides recommendations regarding the key factors and procedures IRBs should consider when reviewing
FDA Policy/General
A Nevada federal court 7/10 entered a consent decree of permanent injunction against Las Vegas-based Bio Health Solutions and its manager/co-owner, Mark Garrison, for selling RenAvast, an unapproved animal drug. According to FDA’s complaint, the firm has marketed RenAvast to treat diseases, including chronic renal
FDA Policy/General
Federal Register notice: FDA has announced a 7/23 virtual public meeting on “Reauthorization of the Prescription Drug User Fee Act.” The meeting will discuss proposed recommendations for reauthorizing the Prescription Drug User Fee Act (PDUFA) for fiscal years 2023 through 2027. A public docket has also been established for
FDA Policy/General
Federal Register notice: FDA is correcting a 5/27 notice on a guidance entitled “Q3C (R8) Recommendations for the Permitted Daily Exposures for Three Solvents--2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl Alcohol — According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents.” The date on page
FDA Policy/General
Federal Register notice: FDA has announced the issuance and reissuance of Emergency Use Authorizations (EUAs) for certain medical devices related to the Covid-19 public health emergency. FDA has issued, and in some cases reissued, EUAs listed in the notice, which includes conditions on the emergency use of the authorized
Biologics
Days after CBER director Peter Marks joined the Trump administration’s Operation Warp Speed project to develop a coronavirus vaccine, he left the group to resume his full-time work at FDA. In a lengthy article based on anonymous interviews with current and former HHS and other officials, Politico says
FDA Policy/General
Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances on, among other things, bioequivalence study designs to support ANDA submissions. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced its process for publishing FDA Emergency Use Authorizations (EUAs) for medical devices related to the Covid-19 public health emergency. FDA is not publishing a separate Notice of Availability (NOA) for each Covid–19 related EUA, but instead it intends to publish periodically a
FDA Policy/General
Federal Register notice: FDA has announced a 6/17-18 Oncologic Drugs Advisory Committee meeting through an online teleconferencing platform. On 6/17, Salarius Pharmaceuticals will present pediatric development plans for SP 2577, and Celgene will present similar plans for marizomib. Both investigational products are under development for an adult
FDA Policy/General
Federal Register notice: FDA has established a public docket to solicit comments on the agency’s “Approved Drug Products With Therapeutic Equivalence Evaluations” (Orange Book). As part of its Drug Competition Action Plan and effort to improve transparency and provide useful information to regulated industry and the public, the agency
FDA Policy/General
Federal Register notice: FDA has established a docket to obtain information and comments from stakeholders about practical steps and successful approaches to establish a rare disease clinical trials network. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Orange Book — Questions and Answers.” The document provides answers to commonly asked questions FDA has received from interested parties about the Orange Book. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has established a docket to solicit comments on the listing of patent information in the agency’s “Approved Drug Products With Therapeutic Equivalence Evaluations”( the Orange Book). FDA is seeking comments on the types of patents currently listed in the Orange Book and the impact that
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: LifeHealth Science, Twinsburg, OH (5/15): FDA inspected the company 11/2020 and found multiple serious violations in the firm’s manufacturing
FDA Policy/General
DEVICES FDA has approved a Boston Scientific PMA for the Emblem MRI Subcutaneous Implantable Defibrillator (S-ICD) System, as well as magnetic resonance (MR) conditional labeling for all previously implanted Emblem S-ICD Systems. “Now with FDA approval, patients receiving the Emblem MRI S-ICD System, as well as patients
FDA Policy/General
Federal Register notice: FDA is providing notification that it approved a drug product that relied on a priority review voucher for approval — Biohaven Pharmaceutical Holding’s NDA for Nurtec ODT (rimegepant) for the acute treatment of migraine in adults. The drug was approved in February based on data from a
FDA Policy/General
Federal Register notice: FDA has made available a final guidance #240 entitled “Proprietary Names for New Animal Drugs.” The document provides recommendations to help new animal drug sponsors develop proprietary names for new animal drugs that do not contribute to medication errors, negatively impact safe use of the drug, or
FDA Policy/General
Federal Register notice: FDA has made available a revised guidance entitled “Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised).” The revision reflects a 5/8 court order that postponed the final rule entitled “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available draft recommendations for new permitted daily exposures (PDEs) for the residual solvents 2-methyltetrahydrofuran, cyclopentyl methyl ether, and tert-butyl alcohol. The PDEs were developed according to the methods for establishing exposure limits included in the guidance for industry entitled “Q3C Impurities: Residual