Drugs
FDA says it has taken its first regulatory actions under Project Orbis, which provides a framework for concurrent submission and review of oncology drugs among its international partners. Under the project, FDA, the Australian Therapeutic Goods Administration and Health Canada collaboratively reviewed applications for two oncology drugs, allowing for simultaneous
FDA Policy/General
The Coalition for Healthcare Communication says five CDER Office of Prescription Drug Promotion research studies are completed and awaiting peer review and publication. Four of the studies look at aspects of direct-to-consumer (DTC) advertising. Coalition executive director Jon Bigelow says the studies “will make an important contribution to
Drugs
GlaxoSmithKline says that while it agrees with FDA’s need to have access to additional supportive files in population pharmacokinetics analyses, the current portal for submissions makes the process challenging. Its comment letter says that very few file types are supported and most of the file formats routinely used by
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Deb USA, Dallas, TX (6/11): FDA inspected the firm 10/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to establish adequate written
FDA Policy/General
Former FDA commissioner Scott Gottlieb has joined Aetion’s board of directors. The health care technology company is working to deliver real-world evidence (RWE) for life science companies, payers, and regulatory agencies. As a board member, Gottlieb will advise the company as it expands the reach and utility of
Drugs
The new FDA Knowledge-aided Assessment & Structured Application (KASA) system “will promote issued-based quality assessment using structured data and information to improve the efficiency, consistency, and objectivity of regulatory actions,” according to six CDER staffers writing in the International Journal of Pharmaceutics. The article says the agency recognized
Drugs
Takeda Pharmaceutical Co. has recalled all doses of Natpara (parathyroid hormone) for injection (25 mcg, 50 mcg, 75 mcg, and 100 mcg) due to a potential issue related to rubber particulates originating from the rubber septum of the product’s cartridge. During a typical 14-day Natpara treatment period, the
Devices
An FDA advisory committee has recommended that FDA should develop standards for device companies to use when communicating any cybersecurity concern to patients. The agency’s Patient Engagement Advisory Committee met 9/10 to discuss communicating to patients about cybersecurity risks. “Preserving the benefit of these devices requires continuous vigilance
FDA Policy/General
Federal Register notice: FDA has made available 53 product-specific guidances (PSGs) – 34 new guidances and 19 revised ones, including 16 PSGs for complex drug products. Five of the new drafts and 11 of the revised drafts are for complex drug products. Nearly half of these 53 PSGs (8 complex
Drugs
FDA has awarded three grants under a pilot program to support developing publicly available clinical outcome assessments (COAs) and related endpoints for specific disease indications (RFA-FD-19-006). “These awards will provide avenues to advance the use of patient input as an important part of drug development that can
FDA Policy/General
Federal Register notice: FDA has revoked an Emergency Use Authorization (EUA) issued to Siemens Healthcare Diagnostics for the Advia Centaur Zika test. The EUA was revoked because Siemens subsequently received clearance for the test under the 510(k) program. To view the notice, click here.
FDA Policy/General
FDA principal deputy commissioner Amy Abernathy tweeted 9/16 that within a month the agency will be rolling out a plan to modernize its information technology approach for its regulatory mission, including reviewing medical product applications. She previously has said this will include modernization of FDA infrastructure to make sure
Drugs
Janssen Pharmaceutical has submitted a supplemental BLA for Tremfya (guselkumab) for treating adult patients with active psoriatic arthritis. The human monoclonal antibody was approved originally 7/2017 for treating adult patients with moderate to severe plaque psoriasis. Janssen says the sBLA is based on results from the Phase 3 DISCOVER-
Drugs
FDA has posted a Form FDA-483 citing Hybrid Pharma (Deerfield Beach, FL) for significant GMP violations documented during a June inspection of the drug outsourcing manufacturer. For example, the company’s procedures designed to prevent microbiological contamination of its drug products did not include adequate validation of the aseptic
FDA Policy/General
Federal Register notice: FDA is seeking comments on a petition requesting exemption from the premarket notification requirements for powered wheeled stretchers. The devices are battery-powered tables with wheels that are intended for use by patients who are unable to propel themselves independently and who must maintain a prone or
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of an Impax ANDA for ursodiol capsules USP, 300 mg. Impax requested the withdrawal based on FDA’s concerns about the validity of bioequivalence data from an undisclosed contract research organization. Ursodiol is used to dissolve certain types of gallstones, to prevent gallstones
Drugs
Former FDA Commissioner Scott Gottlieb has been appointed to the FasterCures advisory board. As a board member, Gottlieb will “leverage decades of experience to provide counsel to the FasterCures team in a variety of areas, including how to best engage patients in research, creating new pathways to innovation through novel
Devices
FDA has cleared a Zimmer Biomet Holdings 510(k) for the JuggerStitch meniscal repair device. The company says that traditional knotted meniscal fixator repair devices typically use hard plastic anchors and surface knots that can damage cartilage. The JuggerStitch device offers an all-suture, knotless approach to meniscal repair, Zimmer
FDA Policy/General
Guide on Special 510(k) Program Federal Register notice: FDA makes available a final guidance entitled “The Special 510(k) Program.” 09/13/2019 FDA Posts 9 OMB-approved Info Collections Federal Register notice: FDA posts a list of ninee information collections that have been approved by OMB. 09/13/
FDA Policy/General
Mylan says it will acquire Meda AB in a $7.2 billion cash-and-stock deal. This was the third attempt by Mylan to buy the Swedish company.The offer, recommended by Meda’s board, valued the company at $9.9 billion, including debt. RedHill Biopharma has submitted to FDA
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “The Special 510(k) Program.” The document provides the framework that FDA uses when considering whether a premarket notification 510(k) is appropriate for review as a Special 510(k). To view the notice, click here.
Drugs
Concerns about an environmental carcinogen that has recently been plaguing blood pressure and heart medicines has now spread to some ranitidine heartburn drugs, including the brand-name drug Zantac, according to an FDA safety alert. The agency says that a nitrosamine impurity called N-nitrosodimethylamine (NDMA), which has been detected