FDA Policy/General
Federal Register notice: FDA is making available two International Council for Harmonization final guidances entitled “Q2(R2) Validation of Analytical Procedures” and “Q14 Analytical Procedure Development.” Q2(R2) provides a general framework for the principles of analytical procedure validation, including validation principles that cover the analytical use of spectroscopic data.
FDA Policy/General
Federal Register notice: FDA is renewing its Gastrointestinal Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 3/3/2026. To view the notice, click here.
Devices
Ventec Life Systems is recalling (Class 1) its VOCSN Patient Breathing Package due to a manufacturing issue that causes the bonded spiral wrap to detach before or during ventilation. “If the spiral wrap detaches, it can compromise the structural integrity, functionality, or cause blockage, stoppage, or leaks in the breathing
Drugs
FDA has published the International Council for Harmonization (ICH) guidance, Q14 Analytical Procedure Development, describing science and risk-based approaches for developing and maintaining analytical procedures suitable for evaluating the quality of drug substances and drug products. The document says that the systematic approach suggested in other ICH guidances can
Drugs
FDA commissioner Robert Califf says he is concerned that the main use of artificial intelligence (AI) algorithms in healthcare will be “decisions that optimize the bottom line rather than optimizing the longevity and well-being of patients.” Speaking 3/5 to the Coalition for Health AI, of which FDA is
Drugs
FDA has published an International Council for Harmonization (ICH) guidance, Q2(R2) Validation of Analytical Procedures, with elements for consideration during the validation of analytical procedures included as part of registration applications. The document includes a collection of terms and their definitions that are meant to bridge the differences that
Drugs
FDA has approved Pfizer’s Besponsa (inotuzumab ozogamicin) for an expanded indication — treating pediatric patients aged one year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). The drug was originally approved in 2017 for the same indication in adults. The expanded use was
Drugs
Four CDER Office of Translational Services researchers say a successful Model-Informed Drug Development (MIDD) pilot program started under PDUFA 6 is leading to an integration of MIDD as part of PDUFA 7. Writing in Clinical Pharmacology & Therapeutics, the researchers say the pilot enabled discussions on the use of
Drugs
FDA has approved a Lantheus Holdings supplemental NDA for an expanded use for ultrasound enhancing agent Definity (perflutren lipid microsphere) in pediatric patients with suboptimal echocardiograms. The approval offers a “valuable tool to opacify the left ventricular chamber and better identify the left ventricular endocardial border,” the company says. The
Devices
FDA has granted Quanterix a breakthrough device designation for its Simoa phospho-Tau 217 (p-Tau 217) blood test as an aid in diagnostically evaluating Alzheimer’s Disease (AD). The company says p-Tau 217 is a “top-performing biomarker” for AD pathology, noting that an Alzheimer’s Association working
FDA Policy/General
Federal Register notice: FDA is announcing its decision to deny a request for a hearing on a CDER-proposed decision to not approve a Vanda Pharmaceuticals supplemental NDA for Hetlioz (tasimelteon) capsules, 20 milligrams (mg) for treating jet lag disorder. “Based on a review of the parties’ submissions, FDA finds
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Applications for FDA Approval To Market a New Drug — 21 CFR Part 314.” The collection supports statutory and regulatory authorities that govern new drugs. The agency is revising Form FDA 3898 (Drug Master File) and the accompanying
Drugs
An FDA 9/11-9/19/23 inspection at the Bell International Laboratories drug manufacturing facility in Eagan, MN, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 2/15 Warning Letter says specific violations were: * failing to establish an adequate quality unit and to
Drugs
A 9/18-9/21/2023 FDA inspection at the Colgin, Inc., drug manufacturing facility in Dallas, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 1/25 Warning Letter says specific violations were: * failing to conduct at least one test to
Devices
An 8/15-9/7/2023 FDA inspection at the Fresenius Kabi USA facility in North Andover, MA, found Quality System and Medical Device Reporting violations in the facility’s work as a specification developer and manufacturer of the Ivenix Infusion System. A just-released 1/4 Warning Letter says
Drugs
FDA has published a guidance, Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes, to help manufacturers and distributors of a new dietary ingredient to submit required premarket safety notifications, known as New Dietary Ingredient Notifications (NDIN). The document focuses on frequently asked questions about the NDIN submission and review
Drugs
The Parenteral Drug Association (PDA) says an FDA “Draft Report and Plan on Best Practices for Guidance” does not provide an overview and metrics on the initiatives in an agency 2011 good guidance practices report. PDA says it suggests that FDA include a section in the draft report with the
Drugs
Sen. Tim Scott (R-SC) and Rep. Earl Carter (R-GA) say they are concerned that a recent FDA draft guidance on advanced manufacturing technologies does not meet Congress’ intent expressed in provisions of their Manufacturing API, Drugs, and Excipients (MADE) in America Act. The guidance implements provisions in the
Drugs
Federal Register notice: FDA is amending its standing advisory committee regulations to add the 12/13/2023 establishment of the Genetic Metabolic Diseases Advisory Committee. The new committee is intended to review and evaluate data on the safety and effectiveness of marketed and investigational human drug and biologic products for
Devices
Smiths Medical ASD has recalled (device correction) its Medfusion model 3500 syringe pump due to software-related issues (before version 6). According to a Smiths recall notice, “Issues associated with earlier software versions of the medical pump include a high-priority alarm for delivery during motor not running, restarting infusion
Drugs
Novo Nordisk says it will file a supplemental NDA this year seeking an expanded label for Ozempic (semaglutide) for preventing progression of kidney impairment and risk of kidney and cardiovascular mortality in people with Type 2 diabetes and chronic kidney disease (CKD). The submission will be based on data from
Drugs
FDA has approved Sandoz’ Jubbonti (denosumab-bbdz) injection as an interchangeable biosimilar to Amgen’s Prolia (denosumab) and Sandoz’ Wyost (denosumab-bbdz) injection as an interchangeable biosimilar to Amgen’s Xgeva (denosumab). An agency statement says Jubbonti is approved for the same treatment indications as Prolia, while Wyost is approved