Biologics
Three people who work in the artificial cell industry say FDA has not yet begun to develop a regulatory framework for artificial cell technologies. “Such lack of preparation for what could be the next forefront of medicine could largely delay the development of these therapies,” the three write in a
Drugs
FDA has accepted and granted priority review to a Biogen NDA for tofersen, an investigational new drug intended to treat superoxide dismutase 1 amyotrophic lateral sclerosis. The agency set a PDUFA action date of 1/25/23 for the NDA. Biogen says it was informed that FDA plans to schedule
Drugs
FDA has granted a Taiho Oncology 2/10 petition asking that the agency not permit ANDA applicants citing Lonsurf (trifluridine and tipiracil) as the reference-listed drug to omit certain labeling information describing pharmacokinetics in and dosage reduction instructions for patients with severe renal impairment and other information from Taiho’
Drugs
Researchers from Cambridge Health Alliance and the University of Mississippi say that after FDA issued Warning Letters targeting specific dietary supplement products, 29% remained available for purchase, with most containing a prohibited ingredient. The researchers looked at FDA Warning Letters targeting the presence of BMPEA or DMHA in 31 supplements.
Devices
FDA has cleared a Northeast Scientific 510(k) for reprocessing Philips’ Spectranetics 0.9mm OTW Turbo-Elite laser atherectomy catheter, which is used to treat peripheral arterial disease. The company says it is the first FDA clearance for reprocessing this type of atherectomy catheter. The device uses high-energy ultraviolet
Devices
FDA has approved a Biotronik PMA for its Pulsar-18 T3 peripheral self-expanding stent system that is designed to improve implantation procedures for endovascular treatments. The device features a 4-French low-profile delivery system that is intended to decrease the risk of access site complications and reduce the
Drugs
Genentech says it is happy to see an FDA flexible approach to meeting the requirements for substantial evidence of effectiveness when faced with clinical trial challenges and the potential need for concomitant antibacterial drug therapy. The company commented on an FDA draft guidance Antibacterial Therapies for Patients With an Unmet
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Orange Book — Questions and Answers.” The document is intended to assist interested parties in using the publication “Approved Drug Products with Therapeutic Equivalence Evaluations” (the Orange Book). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Failure To Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe.” The document is intended to assist applicants in responding to complete response letters (CRLs) on ANDAs. It provides information and recommendations about certain actions ANDA applicants
Drugs
Medexus Pharmaceuticals says its medac licensor has resubmitted its NDA for treosulfan, indicated for combination use with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT). The current submission includes updates to data files and supporting information in response to an FDA information request in May
Devices
Philips says it is undergoing discussions with the Department of Justice (DoJ) on behalf of FDA about the proposed terms of a consent decree involving the company’s troubled Respironics unit and its ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. In late April, the
Devices
Medical device maker Biotronik has agreed to pay $13 million to resolve allegations that it violated the False Claims Act by causing false claims to be submitted to Medicare and Medicaid by paying kickbacks to physicians to induce their use of the companys’s implantable cardiac devices, such as pacemakers
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Conducting Remote Regulatory Assessments — Questions and Answers.” The document describes the agency’s current thinking regarding its use of remote regulatory assessments (RRAs) to increase industry’s understanding of RRAs and facilitate FDA’s process for conducting RRAs. It
FDA Policy/General
Federal Register notice: FDA is issuing an order debarring Kenneth Zipperer for five years from importing or offering for import any drug into the U.S. FDA bases the order on a finding that Zipperer was convicted of one felony count for mail fraud related to the importation of a
FDA Policy/General
Federal Register proposed rule: FDA is proposing to amend its regulations on the format of the National Drug Code (NDC), an FDA standard for uniquely identifying drug products marketed in the U.S. Specifically, all NDCs will be required to be 12 digits in length with three distinct segments and
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices.” The document explains FDA’s compliance policy regarding Global Unique Device Identification Database (GUDID)
Devices
Baxter Healthcare has recalled (Class 1) its Abacus software application due to a risk that final printed bag labels for compounded mixtures may contain incorrect information. The software performs calculations for compounding liquid doses of medications. “When connected to a compounder that mixes these doses according to the calculation, the
Biologics
FDA has accepted for review a Sandoz BLA for what the company describes as the first biosimilar copy of Biogen’s Tysabri (natalizumab). The submission seeks approval for all indications of the reference product, which include relapsing forms of multiple sclerosis including clinically isolated syndrome, relapsing-remitting MS, active secondary
Drugs
FDA has made available a draft guidance entitled “Real-Time Oncology Review (RTOR).” The review program was rolled out 2/2018 to promote earlier submission of topline results (i.e., efficacy and safety results from clinical studies before the study report is completed) and datasets, after database lock, to support
Drugs
FDA has accepted for priority review a Daiichi Sankyo and AstraZeneca supplemental BLA for Enhertu (fam-trastuzumab deruxtecan-nxki) for treating adult patients with unresectable or metastatic HER2 low breast cancer who have received a prior therapy in the metastatic setting. The agency has set a user fee review action
Drugs
FDA has released a draft guidance on the expanded use of remote regulatory assessments (RRAs) beyond the Covid-19 pandemic to assess an FDA-regulated establishment and its records to determine compliance in lieu of conducting a physical inspection. The agency notes that RRAs will be an additional regulatory tool
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of three NDAs from multiple holders because they repeatedly failed to file required annual reports. They are: * NDA 008284 — Panray Corp’s cortisone acetate tablets (5 mg and 25 mg) * NDA 009659 — Panray Corp’s hydrocortisone tablets (10 mg and 20 mg) * NDA