Biologics
Researchers from the University of Rochester and around the world who are members of the RENOIR Clinical Trial Group say a Phase 3 trial of Pfizer’s investigational bivalent RSV (respiratory syncytial virus) prefusion F protein-based (RSVpreF) vaccine prevented RSV-associated lower respiratory tract illness and RSV-associated acute
Drugs
Members of the International Council for Harmonization Regulatory Assembly have approved the M7(R2) guideline, Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, that emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to
Devices
FDA is soliciting responses to five questions as part of its commitment to meeting the MDUFA 5 performance goals by taking actions to engage patients and incorporate their perspectives in the regulatory process. An agency notice says FDA is considering revising a final guidance, Patient Preference Information—Voluntary Submission, Review
FDA Policy/General
Federal Register notice: FDA is extending the comment period for a draft guidance entitled “Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development.” Comments now can be submitted until 5/15. To view the notice, click here.
Biologics
CBER’s Office of Compliance and Biologics Quality has issued an untitled letter to Fidia Pharma USA after reviewing the company’s Web sites and determining that its cell/tissue products require a BLA or NDA. The product, NuDYN, is derived from amniotic membrane and marketed for treating various orthopedic
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making.” The document is the last of four in a series of methodological patient-focused guidances that describe how stakeholders (patients, researchers, medical product developers, and
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.” The document provides recommendations to manufacturers about providing FDA timely, informative notifications about changes in the production of certain finished drugs
Drugs
Rejecting a Covis Pharma proposal for a voluntary phased withdrawal of its preterm birth drug Makena (hydroxyprogesterone caproate injection) over several months, FDA commissioner Robert Califf and chief scientist Namandjé Bumpus said 4/6 that “Makena and its generics are no longer approved and cannot lawfully be distributed in interstate
Devices
FDA has cleared a restor3d 510(k) for the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. The 3-D manufactured patient-specific resection device is made from titanium alloy, and its streamlined features are designed to sit on the bone and offer greater
Drugs
The Department of Justice says two men from New Braunfels, TX, pleaded guilty in a Texas federal court to selling non-controlled but dangerous substances through the mail. A department statement says Evan Field and Michael Diaz bought bulk quantities of drugs such as synthetic opioids and benzodiazepines and re-
FDA Policy/General
FDA has accepted for review an Accord BioPharma BLA for HLX02, a proposed trastuzumab (Roche’s Herceptin) biosimilar for adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The submission, according to
Drugs
FDA has published a draft guidance, Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the Federal Food, Drug, and Cosmetic Act, to assist applicants and manufacturers to provide FDA timely, informative notifications about changes in the production of certain finished drugs and biological products and
Devices
A Roll Call analysis of efforts to date to develop a pandemic preparedness reauthorization bill indicates that FDA oversight of laboratory-developed diagnostic tests is likely to be part of the debate. The article says the effort to strengthen FDA oversight was dropped at the end of 2022 amid House
Drugs
FDA has released the form FDA-483 issued following a 7/11-8/18/22 inspection at QuVa Pharma, a Sugar Land, TX, outsourcing facility. The three inspection observations were: * employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions;
FDA Policy/General
CDER director Patrizia Cavazzoni says the Center is in “growth mode” after the user fee reauthorization on 9/30/2022, and focused on hiring and staff retention. Speaking at an online Alliance for a Stronger FDA 4/5 update, Cavazzoni said CDER’s staff is over the 5,600 level
Devices
FDA has approved a Synapse Biomedical PMA for the NeuRx Diaphragm Pacing System for use in patients with spinal cord injuries who rely on mechanical ventilation. The company says the device is designed as an option for spinal cord injury (SCI) patients who prefer a “more natural method of breathing.
FDA Policy/General
Federal Register notice: FDA announces the availability of a draft guidance entitled “Human User Safety (HUS) in New and Abbreviated New Animal Drug Applications.” The document is intended to clarify the current approaches and CVM’s recommendations) for HUS assessments and information submissions to support the overall safety of proposed
Drugs
FDA has published a draft guidance, Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision-Making, which is the last in a series of four methodological patient-focused drug development guidances that describe how stakeholders can collect and submit patient experience data and other relevant information
Devices
Three former top officials at Magellan Diagnostics (Billerica, MA) have been charged over their role in allegedly concealing a device malfunction that produced inaccurately low lead test results for tens of thousands of children and other patients. Former CEO Amy Winslow, former chief operating officer Hossein Maleknia, and former quality
Drugs
A 2001 and 2002 FDA inspection of the Aspire Pharmaceuticals dietary supplement and drug manufacturing facility in Somerset, NJ, identified significant violations of the Federal Food, Drug, and Cosmetic Act and its regulations. A just-released 11/22/22 Warning Letter said specific violations were: * failing to ensure that the
Drugs
A 4/3 Scorpion Capital LLC petition calls on FDA to withdraw approval for Harmony Biosciences’ Wakix (pitolisant) and take other actions against the drug. Wakix has been indicated to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. The Scorpion Web site says the firm “specializes in intensive,
Drugs
CDER has issued an updated Office of Clinical Pharmacology (OCP) Manual of Policies and Procedures (MAPP), “OCP Prioritization, Triage, and Review Process for INDs and Pre-INDs,” with good review management principles and practices for submissions during the IND phase of drug development. The MAPP says it promotes excellence in