Drugs
A 6/30 Bloomberg editorial is calling for better FDA regulation and more transparency in dealing with generic drugs and active pharmaceutical ingredients coming from abroad. The editorial is critical of recent uncovered serious lapses in quality control at Indian pharmaceutical factories making generic drugs for U.S. consumers. “These
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs for Treatment.” The document addresses the agency’s current thinking on trial population and design, effectiveness, statistical analysis, and safety for drugs being developed for such indications. To view the notice, click
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB. They are: * Hazard Analysis and Critical Control Point (HACCP) Procedures for the Safe and Sanitary Processing and Importing of Juice * Monthly Monitoring Study * Premarket Approval of Medical Devices * Patent Term Restoration, Due Diligence
Devices
LumiraDx Ltd. has submitted a 510(k) to gain clearance for its five-minute Covid Ultra Test and the LumiraDx Instrument. LumiraDx had previously received various Emergency Use Authorizations for its Covid tests during the pandemic. “Once reviewed, this submission should facilitate further submissions to the FDA with focus switching
Devices
FDA says it has accepted the first master file for participation in the 510(k) Ethylene Oxide (EO) Sterility Change Master File Pilot Program. Under the program, 510(k) holders of devices labeled as sterile that want to begin using Andersen Sterilizers EO-Flexible Chamber Technology (EO-FCT) systems to
FDA Policy/General
In annual observance of the Fourth of July (Independence Day) holiday in the U.S., the news operations of FDA Webview are closed until Monday, July 10. The next overnight email news bulletin from this site will be issued that evening.
FDA Policy/General
Federal Register notice: FDA is announcing the availability of the draft guidance entitled “Patient-Matched Guides to Orthopedic Implants.” The document provides recommendations on information that should be included in regulatory submissions for such devices. It also offers recommendations that manufacturers should consider when developing their design process for these
Drugs
FDA has published a guidance, Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment, to assist sponsors to develop drugs or biological products to treat chronic rhinosinusitis with nasal polyps (CRSwNP). The document discusses the agency’s current thinking about trial population and design, effectiveness, statistical analysis, and safety for
Drugs
The FDA Compounding Quality Center of Excellence has posted a Frequently Asked Questions document on compounding inspections and oversight. The document contains 14 questions and answers about agency inspections and enforcement actions.
Drugs
FDA has approved CellTrans’ Lantidra (donislecel), the first allogeneic pancreatic islet cellular therapy made from deceased donor pancreatic cells to treat Type 1 diabetes. An agency announcement says Lantidra is approved to treat adults with Type 1 diabetes who are unable to approach targeted glycated hemoglobin due to current repeated
FDA Policy/General
Federal Register notice: FDA has submitted an information collection revision to OMB entitled “FDA Advisory Committee Regulations." The collection supports agency regulations found in 21 CFR Part 14 that govern procedures applicable to presenting information and views before an advisory committee. It also governs administrative procedures to follow for
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Accreditation Scheme for Conformity Assessment Program.” The revision reflects recent legislative changes, such as amendments made to Section 514 by the FDA Reauthorization Act of 2022 and the Medical Device User Fee Amendments of 2022. These addressed
Drugs
FDA has released an 18-page form FDA-483 with 11 observations from a 6/5-6/13 inspection at Ipca Laboratories, an active pharmaceutical ingredient (API) manufacturer in Ratlam, Madhya Pradesh, India. The observations were: * investigations are inadequate to determine the root cause for the failure of a batch
Drugs
FDA has approved a BioMarin Pharmaceutical BLA for Roctavian (valoctocogene roxaparvovec-rvox) gene therapy for treating adults with severe hemophilia A without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an agency-approved test. Hemophilia A is a rare, genetic condition caused by a mutation in the gene
Biologics
FDA has issued Alvotech a complete response letter (CRL) for its BLA for AVT02, a high-concentration biosimilar candidate referencing AbbVie’s Humira (adalimumab). The letter cites manufacturing deficiencies that were documented during a 3/17 reinspection of the company’s Reykjavik, Iceland facility, according to the company. “The CRL
Devices
FDA has cleared two Roche assays that measure two biomarkers of Alzheimer's pathology — beta-amyloid and tau proteins — in adults over 55 being diagnosed with Alzheimer’s disease. The Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF (tTau) assays “can detect Alzheimer’s
Drugs
Researchers from the FDA Oncology Center of Excellence, the American Association for Cancer Research (AACR), and five leading drug companies say that meeting the need of all cancer patients will require a major shift to prioritize participant diversity in the clinical development of oncology drugs. Writing in Clinical Cancer Research,
Devices
FDA has cleared a Cresilon 510(k) for Cresilon Hemostatic Gel to rapidly control bleeding without the need for manual pressure. The plant-based hydrogel works instantaneously to both stop and control bleeding at the point of care, according to the company. It is intended for the local management of
Devices
FDA has published a draft guidance, Patient-Matched Guides to Orthopedic Implants, with recommendations on information that should be included in regulatory submissions for patient-matched guides to orthopedic implants. The document also has recommendations that manufacturers should consider when developing their design process for this device type. “Patient-matched
Drugs
FDA and National Cancer Institute researchers say the cancer treatment landscape has changed dramatically since 2000, resulting in substantial improvements in patient outcomes. Writing in Nature Reviews Drug Discovery, the researchers summarize trends in the approval of oncology therapeutic products by FDA from 1/2000 to 10/2022, based on
Biologics
CBER has issued an updated calendar year 2023 guidance agenda. The updated document lists the guidances the Center currently intends to develop in three categories: Blood and Blood Components (6 guidances). Therapeutic Products (6 guidances), and Other (1 guidance).
Drugs
Sens. Rick Scott (R-SC), J.D. Vance (R-OH) and Mike Braun (R-IN) are asking FDA for information on why the agency is allowing unapproved cancer drugs from China into the U.S. “rather than addressing the needs of older adults who are impacted by drug shortages.” In