Devices
AdvaMedDx says it appreciates what FDA has done to review and clarify its policies on study designs that can support both 510(k) and CLIA waiver applications. In comments, it notes that it also commented on a related docket on select updates for recommendations for CLIA waiver applications for manufacturers
FDA Policy/General
Federal Register notice: FDA has issued an order withdrawing approval of ANDAs for certain prescription laxatives with the active ingredient polyethylene glycol 3350 (PEG 3350) because the drug products are misbranded. The order is in response to a change in Braintree Labs’ MiraLAX’s status from prescription to nonprescription status.
Drugs
FDA and the International Medication Safety Network have announced a 6/19-20 international summit on medication safety issues. “To achieve a reduction of overall harm related to medication errors, harmonization at the global level is desirable,” an FDA notice says. Product container labeling, and packaging issues are common among
Devices
FDA has approved an Abiomed PMA for its expanded Impella CP heart pump with SmartAssist. The device includes advanced software and new optical sensor that is intended to improve real-time, exact positioning for the pump and allows for repositioning without the need for imaging equipment, according to the company.
Drugs
U.S. Senators Susan Collins (R-ME), Claire McCaskill (D-MO), and Catherine Cortez Masto (D-NV) have sent a letter to Tri-Source Pharma CEO Robert DiCrisci, asking for an explanation on why a 40-year-old, off-patent cancer drug, lomustine, has experienced a recent price increase of
Drugs
Promius Pharma, a Dr. Reddy’s Laboratories subsidiary, has filed an NDA New for its migraine candidate DFN-02, an intranasal formulation of sumatriptan 10 mg and Aegis Therapeutics’ permeation-enhancing technology known as Intravail. “This formulation of DFN-02 allows sumatriptan to be rapidly absorbed into the systemic circulation,
FDA Policy/General
Federal Register notice: FDA has made available a draft five-year plan describing its approach to further implement a structured benefit-risk assessment that includes the patient’s voice in drug development and decision-making. The new draft plan is an update to a similar plan published in 2013. To
Devices
FDA has cleared a Zimmer Biomet Holdings 510(k) for its Comprehensive Augmented Baseplate, which is intended to offer an alternative to bone grafting and eccentric reaming for patients with glenoid defects undergoing shoulder reconstruction. The device features a simplified circular design at three augment heights (3mm, 5mm and 7mm
Drugs
FDA has issued Alkermes a Refusal to File letter on its NDA for New ALKS 5461 (buprenorphine and samidorphan), a once-daily, oral investigational medicine for the adjunctive treatment of major depressive disorder in patients with an inadequate response to standard antidepressant therapies. According to the company, FDA said it
FDA Policy/General
Federal Register Final Rule; technical amendment: FDA is amending its good guidance practices regulation to inform the public on how to electronically submit a draft of a proposed guidance to the agency. The amendment provides an option for submitting such drafts electronically through regulations.gov at Docket No. FDA-2013-
FDA Policy/General
Federal Register notice: FDA has announced a 5/11 public workshop on medical gas regulation entitled “Medical Gas Regulation: Workshop 3.” The topic to be discussed is potential areas for drug regulation that should be revised for medical gases. To view the notice, click here.
Drugs
Vertice Pharma has petitioned FDA to revise and make more stringent bioequivalence requirements outlined in its “Draft Guidance for Sucralfate Oral Suspension.” In the petition, the company asks the agency to “remove the requirement that a generic sucralfate oral suspension formulation must be both qualitatively and quantitatively the same as
FDA Policy/General
Joint Panel to Discuss Celebrex Safety Data Federal Register notice: FDA announces a 4/24-25 joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting to discuss Celebrex safety v. ibuprofen or naproxen. 03/30/2018 Workshop on Generic Regulatory Science Initiatives Federal Register notice: FDA
FDA Policy/General
Federal Register notice: FDA has announced a 5/24 public workshop on “FY 2018 Generic Drug Regulatory Science Initiatives” to provide an overview of regulatory science initiatives for generic drugs and an opportunity for public input. The workshop is mandated by the recent user fee agreement to develop an annual
FDA Policy/General
Federal Register notice: FDA has announced a 4/24-25 joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting. Panel members are scheduled to discuss a Pfizer supplemental NDA for Celebrex (celecoxib) capsules and the results from the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety
Drugs
FDA has approved Foundation Medicine’s FoundationOne CDx (F1CDx), a next generation sequencing-based in vitro diagnostic test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. The sponsor says that unlike other companion diagnostics, the F1CDx is a more extensive test
Drugs
FDA has released two user fee-related implementation plans as part of the recent user fee reauthorization. The first is the “Resource Capacity Planning & Modernized Time Reporting Implementation Plan,” which outlines an approach to “develop capabilities that will help ensure that the FDA is making optimal use of its
Drugs
Sunovion Pharmaceuticals has submitted an NDA for APL-130277 (apomorphine) sublingual film, indicated for treating motor fluctuations (Off episodes) in patients with Parkinson’s disease. The NDA is supported by data from a pivotal, Phase 3 study, CTH-300, which met its primary and key secondary endpoint. In the study,
Devices
FDA’s Clinical Chemistry and Clinical Toxicology Devices Advisory Committee has voted unanimously to recommend approval of Senseonics Holdings’ Eversense, a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes. The device uses a sensor that can last up to 90 days. The company demonstrated the safety,
FDA Policy/General
Federal Register notice: FDA has announced a 5/22 joint Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee advisory committee meeting. Panel members are scheduled to discuss an Insys Development NDA for buprenorphine sublingual spray, indicated for treating moderate-to-severe acute pain
Drugs
A Government Accountability Office (GAO) review says that stakeholder organizations have mixed views about FDA monitoring of Mifeprex since its 2000 approval with an indication for the medical termination of early pregnancy. Members of Congress asked GAO to review FDA’s 2016 relabeling of Mifeprex with a revised indication and
Drugs
A New York federal judge has entered a consent decree sought by FDA against Riddhi USA, ordering the company to stop selling its products until it complies with agency dietary supplement manufacturing regulations and other conditions in the decree. An agency news release says FDA alleged that the company was