FDA Policy/General
Federal Register notice: FDA is withdrawing two guidances — “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act” and “Covid–19: Potency Assay Consideration for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS–CoV–2 Infectivity.” The agency says they are
Drugs
FDA says Hygienic Labs in Denver, CO, a manufacturer of over-the-counter (OTC) drug products, has not responded to several agency requests for records and other information. In a just-released 9/19 Warning Letter, the agency says it is unlawful to refuse to permit access to or copying
Drugs
Bristol Myers Squibb says it will seek approval for a subcutaneous formulation of its Opdivo (nivolumab) for use in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy. The company’s decision to seek approval is based on new data from the
Biologics
FDA has published a revised guidance entitled “Development and Licensure of Vaccines to Prevent Covid-19.” It updates the guidance under the same name that was released 8/2020. The document is intended to assist the agency and sponsors in the clinical development and licensure of vaccines for preventing Covid.
Drugs
Nine staff members in various positions in FDA, CDER, and CBER say the terms real-world data (RWD) and real-world evidence (RWE) are often used interchangeably and inconsistently, including in submissions to the agency involving RWE to evaluate the effectiveness of drugs and biologic products. Writing in an open-
Biologics
FDA has published a guidance, Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies, describing a CBER program to identify and recognize voluntary consensus standards (VCS) to facilitate the development and assessment of regenerative medicine therapy (RMT) products when such standards are appropriate. The document says CBER encourages the use
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of eight ANDAs after the applicants notified the agency that the products were no longer marketed and requested that their ANDAs be withdrawn. To view the notice, click here.
Devices
FDA has added 171 medical devices to its list of artificial intelligence (AI) and machine learning (ML)-enabled devices legally marketed in the U.S. by 510(k) clearance, de novo request, or premarket approval. Of the new additions to the list, 155 are devices with final decision dates between
Drugs
A 3/2-3/10 FDA inspection at Nectar Lifesciences in Chandigarh, India, found significant repeat violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released Untitled Letter says the specific violations were: * failing to establish appropriate written procedures that are designed to prevent microbiological contamination
Drugs
FDA has published a guidance, Benefit-Risk Assessment for New Drug and Biological Products, to tell drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain FDA premarket and postmarket regulatory decisions on NDAs and BLAs. The document addresses decisions
Devices
FDA has granted SeaStar Medical Holding a breakthrough device designation for its cell-directed Selective Cytopheretic Device (SCD) for use in intensive care unit patients with acute kidney injury and acute chronic liver failure. “Hepatorenal syndrome is characterized by an abrupt deterioration of kidney function, driven by a hyperinflammatory process
Devices
Hamilton Medical is recalling its Hamilton-C1, T1, MR-1 ventilators because the capacitators may leak electrolyte fluid onto the ventilator’s control board. “If the control board contacts the electrolyte fluid, the control board or installed spare parts could short circuit,” a recall notice says. The short circuit could
Drugs
Harvard Medical School professor Jerry Avorn thinks recent court decisions involving “compelled speech” could end up limiting FDA’s ability to ensure that drug makers accurately describe their products’ side effects. Writing in a New England Journal of Medicine Perspective column, Avorn cites the Supreme Court decision in 303 Creative
Devices
Seven Gibson Dunn attorneys say cybersecurity is a major focus for government False Claims Act (FCA) investigations. Writing in an online post, the attorneys say that in light of recent new medical device cybersecurity requirements, content in premarket submissions to FDA on cybersecurity procedures and disclosures “constitute another area of
Biologics
BrainStorm Cell Therapeutics says it is withdrawing its BLA for NurOwn to treat amyotrophic lateral sclerosis (ALS), a move it says was coordinated with FDA. A company statement says the agency invited BrainStorm to request an expedited face-to-face meeting to discuss a path forward for NurOwn. BrainStorm says
FDA Policy/General
Federal Register notice: FDA is publishing a list of six information collections that have been approved by OMB under the Paperwork Reduction Act of 1995. They are: * Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 * Voluntary Qualified Importer Program * Radioactive
FDA Policy/General
Federal Register notice: FDA has determined that Fresenius Kabi USA’s Naropin (ropivacaine HCl) solution was not withdrawn due to safety or effectiveness reasons. The determination means that the agency will continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. Naropin
Devices
FDA has published a guidance, Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring, to extend the enforcement policies for the devices beyond the 5/11 expiration of the Covid-19 public health emergency and a 180-day period announced in a 3/13 Federal Register
Biologics
FDA has approved a UCB BLA for Bimzelx (bimekizumab-bkzx) for treating moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The company says the therapy is designed to selectively inhibit two key cytokines driving inflammatory processes – interleukin 17A and interleukin 17F. The approval
Drugs
FDA has cleared an Intellia Therapeutics IND for its NTLA-2001 to treat transthyretin amyloidosis with cardiomyopathy. The company says a global Phase 3 study of the drug is expected to start by the end of this year. NTLA-2001 is described as the first CRISPR therapy candidate to be
Devices
FDA has cleared a GE HealthCare 510(k) for its Allia IGS Pulse imaging system. The device features a monopolar x-ray tube used to capture images for interventional procedures. “The small footprint of the new tube also helps clinicians reach steep angulation for better understanding of coronary artery anatomy,
Devices
FDA has cleared a Praxis Medical 510(k) for its EndoCore EBUS-TBNA fine needle biopsy device. “Endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) is used for the diagnosis and staging of lung cancer,” the company says. “This procedure is performed by inserting a long, flexible fine needle through