Devices
FDA has granted Abiomed 510(k) clearance for an all-in-one, compact cardiopulmonary bypass system called the Abiomed Breethe OXY-1 System. The device provides cardiopulmonary bypass support for patients whose lungs can no longer provide sufficient end organ oxygenation. It is intended to pump, oxygenate, and remove carbon
Biologics
FDA has deferred a review action on a Spectrum Pharmaceuticals BLA for Rolontis (eflapegrastim), indicated for treating neutropenia in patients receiving myelosuppressive anti-cancer drugs, because of a Covid-19-related travel restriction that prevents the agency from inspecting the firm’s South Korea manufacturing plant. The agency told the
Devices
FDA has approved a Medtronic PMA for its Abre venous self-expanding stent system. The device is indicated for use in the iliofemoral veins in patients with symptomatic iliofemoral venous outflow obstruction (also known as deep venous obstruction). “If left untreated, patients can experience leg discomfort and pain, limiting their
Drugs
Janssen Pharmaceutical Companies has submitted a supplemental NDA for a new indication to expand the use of Xarelto (rivaroxaban) in patients with peripheral artery disease (PAD). “If approved, this new indication for the Xarelto vascular dose (2.5 mg twice daily plus aspirin 75-100 mg once daily) would include
Drugs
Federal Register notice: FDA has made available a final standard memorandum of understanding (MOU) entitled “Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the [insert State Board of Pharmacy or Other Appropriate State Agency] and the U.S. Food and Drug Administration.” The MOU describes the
Devices
FDA has revised its template that provides current recommendations about data and information that should be submitted to support a pre-Emergency Use Authorization submission for a Covid-19 antigen test. The template is intended to help test developers provide validation data and other information, but it says alternative approaches
Drugs
FDA has accepted for review a Santen NDA for cyclosporine topical ophthalmic emulsion, 0.1% for treating severe vernal keratoconjunctivitis (VKC) in patients aged 4-18 years. VKC is a rare and recurrent allergic eye condition, most common in children and adolescents, that causes severe inflammation on the eye’s
Drugs
FDA has lifted a clinical hold against AstraZeneca and the University of Oxford to resume clinical trials of their coronavirus vaccine, AZD1222. The hold was imposed in September after Oxford had said a patient’s neurological problem was detected, but it was likely not related to the vaccine. Clinical trials
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,
Devices
CDRH officials are looking to identify the least amount of information that device companies need to support a declaration of conformity to a recognized standard. During a 10/15 Web cast (see transcript) on the Center’s recently issued final guidance on Recognition and Withdrawal of Voluntary Consensus Standards, CDRH
Devices
FDA has granted Neuro Event Labs a breakthrough device designation for its Nelli, a device designed to automate the identification of seizure events using video, audio and sophisticated software algorithms through artificial intelligence. “With Nelli, patients don't have to wear anything,” the company says. “They just have to
Biologics
Several health experts are attacking FDA’s recent guidance on minimum requirements for Covid-19 vaccines to obtain an emergency use authorization (EUA). In comments offered during a 10/22 FDA Vaccines and Related Biological Products Advisory Committee meeting, National Center for Health Research president Diana Zuckerman said the vaccine
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
Drugs
FDA has sent For Our Vets (Mesa, AZ) a Warning Letter after reviewing its Web site and social media sites and determined that it offers cannabinoid (CBD) products for sale that are intended to mitigate, prevent, treat, diagnose, or cure Covid-19, making them unapproved drugs. FDA said it was
Drugs
New Delhi-based Aurobindo Pharma says that its U.S subsidiary AuroLife Pharma has received a Warning Letter based on an inspection at its oral solid manufacturing facility in Dayton, NJ. The company reported in June that it received a Form 483 citing nine GMP observations. The agency notified the
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
Biologics
FDA reportedly has completed its review of a serious illness in an AstraZeneca Covid vaccine study participant and is ready to authorize the company to resume its trial. Four sources told Reuters that the trial is likely to resume as early as this week. The news service reports that the
Drugs
The CDER Office of Generic Drugs has awarded a two-year $1.1 million contract to EpiVax and CUBRC to continue research performed during a previous two-year collaboration. EpiVax says that in the previous contract period it demonstrated the value of in silico tools and in vitro validation methods
Drugs
FDA has announced an additional three-year delay in enforcement of the requirement for wholesale distributors to verify saleable returned product as required under the Federal Food, Drug, and Cosmetic Act. A 2019 compliance policy said enforcement of the requirement would be delayed until 11/27/20. The agency has
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