Drugs
Public Citizen says that groups that oppose congressional principles to make future Covid-19 treatments and vaccines affordable and available for any manufacturer to produce have received millions of dollars in contributions from the drug industry in recent years. In a media statement, the advocacy group says that in early
Biologics
Two University of Pennsylvania Perelman School of Medicine professors say FDA must apply “rigorous standards” when considering whether to approve a coronavirus vaccine. Writing in a Washington Post op-ed, they note that “already the White House has been accused of pressuring government agencies to put politics before science when
Drugs
Government Accountability Office (GAO) healthcare director Mary Denigan Maculey says that the outbreak of Covid-19 has added “a level of complexity” to an already strained FDA system for inspecting drug manufacturers in foreign countries. Testifying before the Senate Finance Committee, Denigan-Maculey said that over the years since the
Biologics
FDA has accepted for review a Y-mAbs Therapeutics BLA for Danyelza (naxitamab) for treating patients with relapsed/refractory high-risk neuroblastoma. The agency has set an 11/30 user fee review action target date, and it has told the company that an advisory committee meeting will not be required.
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
Drugs
FDA has posted a 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 Guidance for IRBs and Clinical Investigators.” The agency says the document is intended to address a “substantial increase in the
Drugs
An FDA internal review obtained by BuzzFeed News through a Freedom of Information Act request says the agency issued emergency use authorizations for two anti-malaria drugs (hydroxychloroquine and chloroquine) touted by President Donald Trump to treat Covid-19 “based on threadbare evidence.” An online post says the review “also
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
Devices
Medtronic has recalled the auto-registration feature of its StealthStation Deep Brain Stimulation (DBS) Software due to inaccuracies caused by minor patient movements during the auto-registration process when used with NexFrame during a DBS procedure, which may not be detected by the surgeon or the device. An FDA recall
Drugs
As the U.S. becomes accustomed to living with the Covid-19 pandemic, FDA commissioner Stephen Hahn says it is time to look forward and evaluate the agency’s response to identify new opportunities. Addressing the Alliance for a Stronger FDA in a virtual update, Hahn said FDA needs to
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
Drugs
A Southern New York federal judge has ordered Sundial Herbal Products to stop distributing unapproved new drugs and misbranded drugs until it complies with federal law. According to the complaint, despite previous warnings from FDA and repeated promises to correct violations, Sundial continued to distribute its products. “The court concluded
Drugs
An FDA safety alert asks patients, caregivers and health care professionals to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present. Letters to consumers and health professionals detail how certain lots of these devices
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
Drugs
CDER director Janet Woodcock says the fifth annual drug safety priorities report issued by the Center “describes the scope and scale of the Center’s drug safety oversight programs, detailing the evolving and wide-ranging nature of our safety operations, with updates on several of the year’s milestones and
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
Drugs
FDA has approved an Avid Radiopharmaceuticals NDA for Tauvid (flortaucipir F18) for intravenous injection, the first drug for helping image a distinctive characteristic of Alzheimer’s disease in the brain called tau pathology. The radioactive diagnostic agent is intended for adult patients with cognitive impairment who are being evaluated for
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
Drugs
FDA is providing a voluntary EUA template for device developers to use for Covid-19 at-home sample collection kits. The template reflects FDA’s current thinking on data and information that they should submit to facilitate the EUA process. In particular, it includes recommendations for use by laboratories and