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applicants after they notified the agency that the drug products were no longer marketed and requested that they be withdrawn.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
Devices
FDA has cleared a Zebra Medical Vision 510(k) for its HealthCXR device intended for use in identifying and triaging pleural effusion in Chest X-rays. The device automatically identifies findings that suggest pleural effusion based on scans, and notifies radiologists, the company says. Pleural effusion is an abnormal accumulation
Devices
FDA says B. Braun has recalled 22 lots of blood administration sets. The recall is due to potential for leakage at the joint between the blood filters and tubing, an FDA statement says. The agency says the recalled sets are used to administer blood from a container to a patient’
FDA Policy/General
The Justice Department says that a Puerto Rico federal grand jury has returned an indictment against Rubén Vázquez-Diaz, charging him with three counts each of introducing misbranded animal drugs, introducing adulterated animal drugs, mail fraud, and wire fraud, and one count of being a drug user in possession of
Drugs
Attorney Joanna Hawana (Mintz) says in an online post that three FDA 11/15 public announcements give the first definitive statements about how the agency intends to apply its existing authorities to cannabidiol and other unapproved cannabis-derived ingredients. The announcements were: * a media statement on Warning Letters issued to
Drugs
FDA has denied without comment a 7/1 US WorldMeds petition asking that the agency: * require any ANDA referencing the company’s Apokyn (apomorphine hydrochloride) injection to seek approval of both the drug and medical device constituent parts of Apokyn; and * establish a policy framework clarifying the circumstances, if any,
Biologics
FDA has ordered Gynecology, Reproductive Endocrinology and Fertility Institute in San Juan, Puerto Rico, and its medical director/owner to immediately cease manufacturing due to significant violations of FDA regulations. An agency statement says an inspection and record review revealed significant violations of regulations on donor eligibility determinations, including donor
Drugs
Evofem Biosciences has resubmitted its NDA for Amphora (L-lactic acid, citric acid and potassium bitartrate), a multipurpose vaginal pH regulator for preventing pregnancy. The submission includes full results from the Phase 3 AMPOWER study, a confirmatory single-arm, open-label Phase 3 trial evaluating the safety and efficacy of
Drugs
The Justice Department says that Heather Alfonso, who worked as an advanced practice registered nurse in a Connecticut pain management center, has been sentenced by a Connecticut federal judge to three years of probation for engaging in a kickback scheme related to fentanyl spray prescriptions. A department statement says that