Drugs
FDA has released the FDA-483 issued following an 8/26-9/26 inspection at Nubratori, Inc., a Torrance, CA, outsourcing facility. The inspection observations were: * failing to establish procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * disinfectant contact time and coverage of the item
Drugs
Immunomedics has resubmitted its BLA seeking accelerated approval for sacituzumab govitecan, indicated for treating patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. In January, FDA issued a complete response letter on the original submission. “The issues related to approvability in
FDA Policy/General
A Ropes&Gray legal analysis says that a recent Supreme Court decision on deference to agencies such as FDA that are interpreting their own regulations has changed the landscape and empowered plaintiffs. “Although FDA will often continue to receive deference in cases involving application of its specialized scientific knowledge
Drugs
Citing a May Supreme Court ruling outlining the standard for a federal preemption defense in drug warning claims, the 3rd Circuit Court of Appeals has remanded to a New Jersey federal court hundreds of Fosamax bone fracture lawsuits, asking that court to decide whether the failure-to-warn cases are
Devices
FDA has cleared a NeuroOne Medical Technologies 510(k) to market its thin film cortical electrode technology for temporary (less than 30 days) recording, monitoring, and stimulation on the surface of the brain. NeuroOne believes that the device is the first cortical electrode to receive FDA 510(k) clearance that
Drugs
Immunomedics has resubmitted its BLA seeking accelerated approval for sacituzumab govitecan, indicated for treating patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. In January, FDA issued a complete response letter on the original submission. “The issues related to approvability in
Drugs
FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy as monotherapy for treating patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or
Drugs
FDA’s Office of New Drugs has denied a Lexicon Pharmaceuticals appeal of a March Complete Response Letter on its NDA for Zynquista (sotagliflozin), a dual SGLT1 and SGLT2 inhibitor for adults with Type 1 diabetes in combination with insulin. Without disclosing FDA’s concerns, the company says the agency
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Ultragenyx’s Crysvita (burosumab-twza), indicated for treating X-linked hypophosphatemia in adult and pediatric patients. The regulatory review period is 3,485 days, which includes 3,241 days that occurred during the testing phase
Drugs
FDA has posted a final guidance entitled “Adaptive Designs for Clinical Trials of Drugs and Biologics.” The document provides recommendations on the appropriate use of adaptive designs for clinical trials to provide evidence of a drug or biologic’s effectiveness and safety. It describes principles for designing, conducting, and reporting
Drugs
FDA says that most recent, interim post-approval study (PAS) results for the Impella RP System continue to show the survival rate for the subgroup of PAS patients who would have met the enrollment criteria for the premarket clinical studies (72.7%, 16 out of 22 patients) is similar to
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension on “Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure Under Section 515A of the Federal Food, Drug,
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 21 ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
Biologics
FDA has ordered Gynecology, Reproductive Endocrinology and Fertility Institute (GREFI) (San Juan, PR) to immediately stop manufacturing cell/tissue products after an October inspection found significant violations. In an 11/25 letter to GREFI, the agency says it does not provide adequate protections against the risks of communicable disease transmission
Devices
FDA has announced a 2/25 public workshop entitled “Evolving Role of Artificial Intelligence in Radiological Imaging.” The workshop will discuss emerging applications of artificial intelligence (AI) in radiological imaging including AI devices intended to automate the diagnostic radiology workflow as well as guided image acquisition. It will also hear
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Novo Nordisk’s Ozempic (semaglutide), indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus. The regulatory review period is 3,336 days, which includes 2,
FDA Policy/General
Tzvi Lexiere Debarred for 10 Years Federal Register notice: FDA debars Tzvi Lexier for 10 years from importing any drug into the U.S. because he was convicted for conspiracy to smuggle and distribute misbranded drugs. 11/27/2019 Six ANDAs Withdrawn by FDA Federal Register notice: FDA withdraws approval
FDA Policy/General
Wave Life Sciences has entered into a research, license and option agreement with Pfizer to investigate developing nucleic acid therapies aimed at silencing the underlying causes of debilitating metabolic diseases. “The collaboration will focus on genetically defined targets and bring together Wave’s proprietary stereopure drug development platform, across antisense
FDA Policy/General
Federal Register notice: FDA has debarred Tzvi Lexier for 10 years from importing any drug into the U.S. because he was convicted for conspiracy to smuggle and distribute misbranded drugs. Lexier was also convicted on one felony count for unlicensed wholesale distribution of prescription drugs. To view the notice,
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of six ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested their withdrawal. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.” The document provides recommendations to applicants regarding whether and when comparative clinical immunogenicity studies may be needed to support licensure of proposed biosimilar and interchangeable recombinant human insulins, recombinant human
Devices
FDA has approved a Qiagen and DiaSorin PMA for the automated workflow for QuantiFeron-TB Plus (QFT-Plus), a fourth-generation test for latent tuberculosis (TB) detection on DiaSorin’s Liaison platforms. The companies say the QFT-Plus offers streamlined laboratory automation for TB screening, and supports the “conversion from