Drugs
In a break from past practices, FDA commissioner Scott Gottlieb says he is forming a work group to explore policy frameworks that could lead to short-term importation of drugs to help resolve specific drug shortage situations. In a statement, Gottlieb says the group will “consider whether and how the
Drugs
CDER director Janet Woodcock says that an FDA reorganization plan submitted to HHS for approval before going to Congress for concurrence will affect nearly one-third of CDER offices. “The changes within CDER offices will enable us to respond to new priorities more efficiently with a stronger organizational framework and
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Labeling for Biosimilar Products.” The document provides recommendations on the prescribing information (package insert), except for certain recommendations pertaining to FDA- approved patient labeling (e.g., Patient Information, Medication Guide, and Instructions for Use). It also provides an overview
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Use of Electronic Health Record (EHR) Data in Clinical Investigations.” The document is intended to facilitate the use of EHR data in clinical investigations and to promote the interoperability of EHR and electronic data capture systems. To view the
Drugs
FDA has released the FDA-483 issued following a 2/26-3/2 inspection at Hetero Drugs, a Sangareddy District, India, active pharmaceutical ingredient producer. The form says specific inspection observations were: * failing to thoroughly review any unexplained discrepancy and failure of a batch or any of its components to
Drugs
FDA has released the FDA-483 issued following a 4/9-5/18 inspection at Akorn, a sterile drug manufacturer in Decatur, IL. Specific observations in the document were: * failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including
Drugs
Ocular Therapeutix has resubmitted its NDA for Dextenza (dexamethasone insert) 0.4mg, indicated for treating ocular pain following ophthalmic surgery. The submission responds to concerns raised in a 7/2017 complete response letter (see earlier story). The agency set a user fee review action target date of 12/28. The
Drugs
FDA has approved Terumo BCT’s sodium citrate 4% solution USP, indicated for anticoagulating whole blood during automated apheresis procedures. The product has been on the agency’s shortage list for over a year and is manufactured at Terumo BCT's facility in Larne, UK, which supplies parts of
Drugs
FDA has placed a clinical hold on a Mersana Therapeutics Phase 1 study of XMT-1522 after the company reported a Grade 5 Serious Adverse Event (patient death) in dose level seven of the therapy. “While the partial clinical hold remains in effect, no new patients will be enrolled in
Drugs
CDER director of professional affairs and stakeholder engagement John Whyte is leaving at the end of August to become chief medical officer at WebMD. In an e-mail to Center staff, director Janet Woodcock says that since Whyte joined CDER in 2013, he has worked with her to increase the
Drugs
FDA says it has approved Novartis’ Kisqali (ribociclib) in combination with an aromatase inhibitor for treating pre/perimenopausal or postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. Kisqali also was approved in combination with fulvestrant for treating postmenopausal women with HR-
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Metal Expandable Biliary Stents — Premarket Notification (510(k)) Submissions.” The document provides recommendations for information and testing that should be included in 510(k) submissions for such devices. To view the notice, click here.
Drugs
FDA has issued an International Conference on Harmonization (ICH) guidance, E17 General Principles for Planning and Design of Multiregional Clinical Trials, to describe general principles for the planning and design of multiregional clinical trials with the aim of increasing the acceptability of such trials in global regulatory submissions. The document
Drugs
FDA has issued a draft question-and-answer guidance to provide its current thinking on the requirements for submission of field alert reports (FARs) by NDA and ANDA applicants. The draft also outlines the agency’s recommendations for FAR submissions to help increase their consistency and relevancy. And it addresses
Devices
FDA has cleared an Adaptiiv 510(k) for its 3D Bolus Software for use in creating customized personal medical devices using 3D printing, primarily for use in treating cancer. The software allows practitioners 3D printing of patient-specific uniform thickness bolus, modulated bolus for MERT (modulated electron radiation therapy), High-
Biologics
FDA has accepted for priority review an Immunomedics BLA for sacituzumab govitecan and its use in treating patients with metastatic triple-negative breast cancer who previously received at least two prior therapies for metastatic disease. Sacituzumab govitecan is described by the company as a novel, first-in-class antibody-drug
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Innovative Approaches for Nonprescription Drug Products.” The document describes two innovative approaches that may be useful to consider for demonstrating safety and effectiveness for a nonprescription drug product in cases where the drug facts labeling alone is not sufficient
Devices
GE Healthcare calls on FDA to continue to employ a risk-based approach to regulating software products, differentiating not only between functions that are not medical devices and those that remain medical devices, but also including a category of products that, based on risk, warrant exercising enforcement discretion. The company’
Drugs
Washington Legal Foundation (WLF) challenges the FDA position that its proposed product jurisdiction rule is intended to merely clarify existing regulations and update them to reflect agency practices and procedures. “WLF respectfully submits that the proposed rule accomplishes neither objective,” its comment letter says. “Nor has FDA taken this opportunity
Drugs
FDA has approved a Janssen Pharmaceutical NDA for Symtuza (darunavir), a single-tablet regimen for treating human immunodeficiency virus type 1 in treatment-naïve and certain virologically suppressed adults. Approval was based on data from two 48-week, non-inferiority, pivotal Phase 3 studies that assessed the safety and efficacy
Drugs
FDA has published a guidance, Use of Electronic Health Record Data in Clinical Investigations, to assist sponsors, clinical investigators, contract research organizations, institutional review boards, and other interested parties in using electronic health record (EHR) data in FDA-regulated clinical investigations. The document defines electronic health systems for its purposes
Drugs
FDA has issued a guidance, Labeling for Biosimilar Products, to help applicants develop draft labeling for proposed biosimilar products for submission in a 351(k) application. The document says its recommendations for prescription drug labeling pertain only to the prescribing information (package insert) except for certain recommendations pertaining to FDA-