Devices
FDA has classified as Class 1 an Edwards Lifesciences recall of its 131F7, 131F7J, 131F7P, 131VF7P, 151F7 Swan-Ganz Thermodilution Catheters manufactured between 12/26/2017 and 4/19/2018. An FDA notice says the recall is due to incorrect assembly and reversal of the catheter tubes (lumens). “If the
Drugs
FDA has issued Alkermes a complete response letter on its NDA for ALKS 5461 for the adjunctive treatment of major depressive disorder. The agency letter requests additional clinical data to provide substantial evidence of the therapy’s effectiveness, according to the company. Alkermes says it plans to meet with FDA
FDA Policy/General
Federal Register notice: FDA has issued a draft guidance, ANDA Submissions—Amendments and Requests for Final Approval to Tentatively Approved ANDAs. The document says it provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fashion to enable final approval on
Devices
FDA has classified as Class 1 a Smiths Medical recall of its sterile saline and sterile water products for inhalation due to the potential exposure to infectious agents (bacillus infantis and staphylococcus epidermidis) from damage to the containers used to package the finished products. Product use in patients could result
Devices
FDA has published a final guidance entitled The Least Burdensome Provision: Concept and Principles, to describe the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles, as required by Congress in the FDA Modernization Act of 1997 for medical device premarket
Drugs
Generic drugs lobbying arm Association for Accessible Medicines (AAM) says it is concerned that new legislation introduced by Congressmen Kurt Schrader (D-OR) and Earl L. Carter (R-GA) may have the “unintended impact of reducing competition in the prescription drug market and thus lead to patients continuing to pay
FDA Policy/General
Federal Register notice: FDA has released a draft International Council for Harmonization guidance, S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines, recommending international standards for nonclinical safety studies recommended to support development of pediatric medicines. The document recommends an approach for the nonclinical safety evaluation of medicines
Drugs
FDA says it is evaluating recent interim post-approval study (PAS) results which suggest a higher mortality rate for patients treated with Abiomed’s Impella RP System than the rate previously observed in premarket clinical studies. The Impella RP System is a temporary right heart pump system intended to help
Devices
Federal Register notice: FDA has posted a guidance on Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody Detection that provides recommendations to facilitate industry development and validation of assays for assessing the immunogenicity of such products during clinical trials. The document includes guidance on
FDA Policy/General
Rare Disease Drug Development Guide Federal Register notice: FDA issues a draft guidance, Rare Diseases: Common Issues in Drug Development, to assist drug and biological sponsors in conducting more efficient and successful drug development programs. 02/01/2019 Guide on REMS Assessment: Planning and Reporting Federal Register notice: FDA makes
Drugs
DRUGS FDA has approved a Mitsubishi Tanabe Pharma America NDA for Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis, commonly known as Lou Gehrig’s disease. The intravenous infusion is intended to be administered with an initial treatment cycle of daily dosing for 14 days, followed by a 14-
Biologics
After 16 years at FDA, CDER Therapeutic Biologics and Biosimilars Staff director Leah Christl is leaving to pursue other opportunities, effective 2/22. She joined FDA in 2003 as a regulatory project manager in the Over-the-Counter Drug Products Division. She later served as associate director for regulatory affairs
FDA Policy/General
Federal Register notice: FDA has issued a draft guidance, Rare Diseases: Common Issues in Drug Development, to assist drug and biological sponsors in conducting more efficient and successful drug development programs. The document revises and replaces an 8/2015 drug guidance by updating the natural history studies section; inclusion of
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled REMS Assessment: Planning and Reporting. The document describes how to develop a risk evaluation and mitigation strategy (REMS) assessment plan, specifically how the REMS program goals, objectives, and REMS design may affect the selection of metrics and data sources,
Devices
Terrific Care/Medex Supply has recalled all lots of Roche Diagnostics’ CoaguChek XS PT Test Strips that were manufactured 10/2017 to 5/2018 due to inaccurate International Normalized Ratio test results, when compared to laboratory results. The test strips may provide results that are higher than the actual INR,
Drugs
West Pharmaceutical Services has recalled its Vial2Bag fluid transfer system that was manufactured between 3/15/2016 and 1/8/2019 due to the possibility that the device may not adequately transfer concentrated medication from a vial to an IV bag before infusion into a patient’s vein. If inadequate
Drugs
Congressmen Kurt Schrader (D-OR) and Earl L. Carter (R-GA) have introduced legislation aimed at keeping drug prices down by increasing competition in the generic drug market. The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act (HR 938) would aim to prevent the
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.” The document is intended to assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test devices and who seek to coordinate
FDA Policy/General
Federal Register notice: FDA has issued a guidance, Safety and Performance Based Pathway, that discusses the agency’s current thinking on expanding the concept of the abbreviated 510(k) program for demonstrating substantial equivalence for 510(k) submissions. The document’s intent is to describe an optional pathway (the Safety
FDA Policy/General
Federal Register notice: FDA has released a draft guidance entitled Survey Methodologies to Assess REMS Goals That Relate to Knowledge that gives information to industry on conducting REMS assessment surveys, used to evaluate respondent knowledge of REMS-related information. The document discusses general principles and recommendations relating to conducting REMS
Devices
FDA has cleared a Qualigen 510(k) for its FastPack IP Sex Hormone Binding Globulin Immunoassay, a biomarker used in diagnosing and treating men’s health. The FastPack IP system is described by the company as a fully automated, highly efficient blood analyzer that provides rapid, quantitative immunoassay results at
Drugs
FDA has issued Sunovion Pharmaceuticals a complete response letter on its NDA for apomorphine sublingual film for use in treating “off episodes” (the re-emergence or worsening of symptoms otherwise controlled by medications) experienced by people living with Parkinson’s disease. In the letter, FDA requested additional information and analyses,