FDA Policy/General
Federal Register notice: FDA is announcing its final decision rendered last month to withdraw approval of Covis Pharma Group’s Makena (hydroxyprogesterone caproate injection) and eight ANDAs that reference the product. The drug had previouslyreceived accelerated approval to reduce the risk of preterm birth in women pregnant with one baby
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.” The document provides revised donor deferral recommendations for individuals with increased risk for transmitting human
FDA Policy/General
Federal Register notice: FDA has determined that 18 drug products listed in the notice were not withdrawn from sale due to safety or effectiveness concerns. The determination allows the agency to continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. To
Drugs
FDA has granted Pyxis Oncology an orphan drug designation for PYX-201 in pancreatic cancer. The company says subject dosing is already underway in a Phase 1 trial known as PYX-201-101. Preliminary data from the trial is expected in early 2024. PYX-201 is described by Pyxis as
Devices
Cordis has recalled (Class 1) its Angioguard RX/XP Emboli Capture Guidewire System due to device separation concerns. “There is a potential for separation of the Angioguard RX/XP delivery system and capture sheath,” a recall notice says, which could lead to an intra-procedural delay, unplanned percutaneous or surgical
Drugs
A bipartisan group of U.S. Senators and House members are urging FDA to step up its regulatory activities to improve rare disease product development and reviews. In a 5/2 letter, the lawmakers ask FDA to “establish an agency task force to, first, identify areas of strength and areas
FDA Policy/General
FDA has approved Astellas Pharma’s Veozah (fezolinetant), an oral drug for treating moderate-to-severe vasomotor symptoms (hot flashes) caused by menopause. The drug is the first neurokinin 3 (NK3) receptor antagonist approved for the indication, according to an agency release. It works by binding to and blocking the
Devices
Now that the Covid-19 public health emergency (PHE) is officially over, FDA is urging medical device makers to maintain the status quo regarding PHE-related authority that required companies to report situations that could lead to device shortages. That authority, Section 506J of the FD&C Act, required
Biologics
FDA has published a guidance, Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products, revising the agency’s recommendations for evaluating blood donor eligibility due to human immunodeficiency virus (HIV) using individual risk-based questions.
Devices
FDA says the Cook Medical 4/7 recall of the Blue Rhino G2Multi Percutaneous Tracheostomy Introducer is Class 1. A notice says the company recalled 3,053 units following customer reports that the tracheostomy in the sets and trays was not making a secure connection with the 15mm cap and
Drugs
FDA has approved an Otsuka Pharmaceutical and Lundbeck supplemental NDA for Rexulti (brexpriprazole) oral tablets for treating agitation associated with dementia due to Alzheimer's disease. Approval was based on data from two 12-week, randomized, double-blind, placebo-controlled studies. “In both studies, patients who received 2 mg
FDA Policy/General
Knowledge Ecology International (KEI), which petitioned FDA in 2020 asking it to ban the use of background music during the presentation of risks in direct-to-consumer (DTC) drug ads, says three groups and seven individuals submitted 5/10 comments to the agency supporting the petition. The petition had already
FDA Policy/General
FDA commissioner Robert Califf and chief medical officer Hilary Marston say the agency is learning from experiences during the Covid-19 public health emergency to better prepare for future public health emergencies, supply chain disruptions, geopolitical changes, and natural disasters. Writing in an FDA Voices online post, Califf and Marston
FDA Policy/General
Federal Register notice: FDA is announcing the publication of a discussion paper entitled “Using Artificial Intelligence (AI) and Machine Learning (ML) in the Development of Drug and Biological Products.” The agency is soliciting feedback on the opportunities and challenges with using AI/ML in drug development, as well as medical
FDA Policy/General
Federal Register notice: FDA has determined that Roxane Laboratories’ hydrochlorothiazide oral solution, 50 mg/5 mL was not withdrawn from sale due to safety or effectiveness concerns. The determination allows the agency to continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory
Devices
FDA has cleared a Sibel Health 510(k) on the ANNE One platform for continuous neonatal and infant monitoring for newborns and infants aged up to two years. The device monitors physiological parameters, such as heart rate, respiratory rate, skin temperature, body temperature, apnea-hypopnea index, total sleep time, snoring,
FDA Policy/General
FDA has issued ImmunityBio a complete response letter on its BLA for Anktiva (N-803) in combination with Bacillus Calmette-Guérin (BCG) for treating patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 disease. The letter cites deficiencies related to
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA efforts to meet its PDUFA 7 commitment to discuss negative control methods in real-world data studies and their potential to enhance and modernize the agency drug safety system. The comments came in response to the FDA 3/8
Drugs
The Council for Responsible Nutrition (CRN) petitioned FDA 3/9 to reconsider how it has been invoking the drug preclusion clause of the Dietary Supplement Health and Education Act (DSHEA). CRN says (includes a link to the petition) that the agency has been and will likely continue to be misapplying
Drugs
FDA has approved expanded Magnetic Resonance Imaging (MRI) labeling for Abbott’s Eterna spinal cord stimulation (SCS) system to include new leads that are magnetic resonance (MR)-conditional. Abbott says the expanded labeling “means people with chronic pain can undergo MRI scans within the approved outlined conditions and have a
Drugs
FDA has published a Study Data Technical Conformance Guide incorporating a prior guidance, Providing Regulatory Submission in Electronic Format — Standardized Study Data. The guide provides specifications, recommendations, and general considerations on how to submit standardized study data using FDA-supported data standards located in the FDA Data Standards Catalog. The
Drugs
AdvaMed says it “strongly supports FDA’s efforts to provide recommendations regarding requirements in clinical investigations for when electronic systems, electronic records, and electronic signatures are considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures.” The association’s comments responded to an FDA draft Q&A