Biologics
The Massachusetts Institute of Technology Center for Biomedical Innovation (CBI) is recommending that FDA use a draft guidance on safety testing of human allogeneic cells expanded for use in cell-based medical products to recommend a transition to the high-throughput sequencing (HTS) molecular-based technology. In its comment letter
FDA Policy/General
House Republican leaders have scrapped a floor vote this week on FDA’s fiscal year 2025 budget. Capitol Hill reports indicate that Republican lawmakers are not in agreement on whether the funding measure should contain language that would have limited access to the abortion pill mifepristone. With no sure path
Drugs
FDA has approved a Mirum Pharmaceuticals label expansion for Livmarli (maralixibat) oral solution for treating cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC). The expanded label includes use in PFIC patients 12 months and older as well as a higher drug concentration formulation evaluated in the company’s
Drugs
Abbott has initiated a medical device correction for some of its FreeStyle Libre 3 sensors distributed in the U.S. during the first half of May. “Internal testing determined that some of the sensors from among three lots may provide incorrect high glucose readings, which if undetected may pose a
Drugs
FDA has opened a public docket to receive information and comments on evaluating and mitigating the immunogenicity risk of host cell proteins (HCPs). A Federal Register notice says the agency is specifically interested in comments on suitable methods to detect, identify, and quantify HCPs, on achievable residual amounts of HCPs
Drugs
FDA has released the form FDA-483 issued following a 6/10-6/14 inspection at Biocon Biosphere, a drug manufacturing facility in Andhra Pradesh, India. The three inspection observations were: * failure to establish written procedures for production and process controls designed to assure that drug products have the identity,
Drugs
Pfizer says it will discuss with FDA plans to seek approval of its investigational gene therapy for treating adults with moderately severe to severe hemophilia A. The move follows just-announced “positive topline results” from the Phase 3 AFFINE study (NCT04370054), according to the company. “The AFFINE study achieved its
FDA Policy/General
Federal Register notice: FDA is announcing that it revoked a Mesa Biotech emergency use authorization for the Accula SARS-CoV-2 Test. The company says it is no longer marketing the test and asked that its authorization be revoked. To view the notice, click here.
Biologics
FDA has created a docket to receive information and comments on how best to advance the development of new biosimilar biological products as part of the agency’s commitments under the Biosimilar User Fee Amendments of 2022. The agency is asking for industry input on whether biosimilar product development would
Drugs
FDA has published a guidance, Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drugs and Biological Products, as part of the agency’s real-world evidence program under the 21st Century Cures Act. The document is intended to provide sponsors and
Drugs
FDA has published a guidance, Container Closure System and Component Changes: Glass Vials and Stoppers, to collate recommendations for appropriate reporting categories and the content of postapproval change submissions across several FDA guidances. The document has recommendations for holders of NDAs, BLAs, and ANDAs about the reporting and implementation of
Drugs
Attorney Julie Tibbets (Goodwin) has identified the two most common bioresearch monitoring (BIMO) violations shown in FY 2023 Warning Letters to clinical investigators. She says the most common violations were: * failure to ensure that the investigation was conducted according to the investigational plan; and * failure to submit an IND application
Drugs
FDA has denied a Novartis 9/12/2022 petition asking that the agency not approve certain ANDAs that cite Entresto (sacubitril and valsartan) tablets in various doses as the reference-listed drug. Specifically, the petition asked that FDA: * not approve any ANDA referencing Entresto until the 2/16/2024 expiration
Drugs
FDA has accepted for filing a Telix Pharmaceuticals NDA for TLX007-CDx, a proprietary cold kit for preparing prostate-specific membrane antigen (PSMA)-PET imaging for prostate cancer. The agency has set a user fee review action target date of 3/24/2025. “If approved, the new kit will enable
Drugs
FDA has released a final guidance entitled “Providing Over-the-Counter Monograph Submissions in Electronic Format.” The document is intended to assist submitters by describing the electronic OTC monograph submissions requirements, and providing recommendations and other information on how to send such submissions to FDA. FDA regulations require that all
Devices
After a 28-year career in federal service, CDRH director Jeff Shuren says he is retiring later this year. Deputy Center director for transformation Michelle Tarver will serve as acting Center director beginning 7/28. To ensure a smooth transition, Shuren is moving to the Commissioner’s Office while FDA
Drugs
A 12/15-12/23/2023 FDA inspection at the Yahon Enterprise Co., Ltd. drug manufacturing facility in Trang Bom District, Vietnam, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 6/5 Warning Letter says specific violations were: * failure to have, for
Drugs
Hikma Pharmaceuticals is extending a Class 1 recall of one lot of acetaminophen injection, 1,000mg/100mL due to the potential presence of a bag labeled dexmedetomidine HCl injection (400mcg/100mL) inside the overwrap that is labeled acetaminophen injection. If providers do not identify the drug inside the acetaminophen overwrap
FDA Policy/General
Federal Register notice: FDA is extending the comment period on its 6/26-released “Information Technology (IT) Strategy” and “Customer Experience Strategy.” Comments can now be submitted until 8/30. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing that OMB has approved an information collection entitled “Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising.” This type of (XXX SUBSTITUTE XXX)advertising may make quantitative claims about a drug’s efficacy or risks, and the agency has research and guidance
Devices
Three stakeholders have submitted information in response to an FDA renewed solicitation for public input on patient safety, including best practices to promote patient safety, education, and competency, associated with medical software functions that are excluded from the medical device definition in the 21st Century Cures Act. Wolters Kluwer cites
Drugs
A 1/15-1/19 FDA inspection at the drug manufacturing facility operated by Brassica Pharma Pvt. Ltd. in Thane, India, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 7/11 Warning Letter says specific violations were: * failure to ensure that laboratory records included