Drugs
FDA says it has updated its Risk Evaluation and Mitigation Strategy (REMS) Web site and structured product labeling (SPL) initiatives. The announcement says the updates are a result of feedback received from stakeholders who asked that the agency provide information on REMS programs in a more direct and user friendly
Drugs
Attorney General Jeff Sessions says the Justice Department is creating an Opioid Fraud and Abuse Detection Unit pilot program to use data to help combat the nation’s opioid crisis. Speaking at the Columbus Police Academy, Sessions said the new unit will focus specifically on opioid-related healthcare fraud using
FDA Policy/General
Federal Register notice: FDA has announced an 8/23 Webinar to provide stakeholders with a status update on the process of FDA and industry discussions on an Over-the- Counter (OTC) Monograph user fee program that began 7/2016. FDA will also provide an overview of proposed performance goals and
Devices
CDRH and the Radiological Society of North America 3D Printing Special Interest Group will hold a joint meeting 8/13 on the clinical use of 3D printed patient-specific anatomic models. The meeting is intended to focus on clinically used models to identify current best practices, levels of benefit vs.
Drugs
Coherus BioSciences has asked the Delaware federal court to delay the start of discovery in Biologics Price Competition and Innovation Act patent litigation with Amgen until after the court resolves a Coherus motion to dismiss Amgen’s suit against it. Attorneys with Patterson Belknap Webb & Tyler say in an
Devices
FDA has approved a Medtronic PMA for its new Avalus pericardial aortic surgical valve for treating aortic valve disease. The device “leverages proven surgical bioprosthetic valve concepts with added features designed to enhance clinical performance, helping to address the contemporary needs of cardiac surgeons, as well as patients who are
FDA Policy/General
Federal Register notice: FDA has announced the fee rates and payment procedures for fiscal year 2018 generic new animal drug user fees. The fee for an abbreviated application for a generic new animal drug is $193,000, and the generic new animal drug product fee is $8,195. To view
FDA Policy/General
Federal Register notice: FDA has announced the fiscal year 2018 rates for the establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities. The FY 2018 rates for the small business establishment fee is $5,364, the non-small business establishment
Drugs
FDA and TG Therapeutics have reached an agreement on a special protocol assessment (SPA) on the design of two Phase 3 clinical trials for TG-1101 (ublituximab), a glyco-engineered anti-CD20 monoclonal antibody for treating relapsing forms of multiple sclerosis (RMS). “The SPA provides agreement that the two Phase
Drugs
A National Bureau of Economic Research (not a government agency) working paper surveying “The Landscape of U.S. Generic Prescription Drug Markets, 2004-2016,” says there is evidence to suggest that prices of generic drugs are statistically significantly increasing over time, particularly following implementation of the 2010 Affordable Care Act
Drugs
FDA has accepted for priority review an AstraZeneca NDA for acalabrutinib, a highly-selective Bruton tyrosine kinase inhibitor for treating patients with relapsed/refractory mantle cell lymphoma who have received at least one prior therapy. The submission is based on results from the Phase 2 ACE-LY-004 clinical trial.
Drugs
FDA has approved an expanded indication for Pharmacyclics’ Imbruvica (ibrutinib) to include chronic graft versus host disease (cGVHD) after failure of one or more treatments. The agency says it is the first approved therapy for treating cGVHD. Imbruvica, a kinase inhibitor, was previously approved for certain indications in treating chronic
Devices
FDA has announced an ambitious series of actions as part of its Digital Health Innovation Action Plan to be completed between now and the first quarter of 2018. Attorney Suzan Onel (Kleinfeld, Kaplan and Becker) writes in an analysis that the agency says it is “redesigning” and “reimagining” its approach
Drugs
FDA has published a draft guidance, Child-Resistant Packaging Statements in Drug Product Labeling, to assist firms that choose to include child-resistant packaging (CRP) statements in the drug product labeling. The guidance discusses what information should be included to support CRP statements in labeling for NDAs, ANDAs, BLAs, and
FDA Policy/General
Federal Register notice: FDA has announced the rates and payment procedures for fiscal year 2018 animal drug user fees. The rates are: $238,100 for an animal drug application; $119,050 for a supplemental animal drug application for which safety or effectiveness data are required; $6,175 for an annual
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new information collection for “De Novo Classification Process (Evaluation of Automatic Class 3 Designation).” The proposed collection is necessary to satisfy statutory requirements for implementing this voluntary submission program. This follow-up collection includes an estimated hour burden for requests for
Drugs
FDA has issued a guidance, Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial Diseases, to assist sponsors in the clinical development of new antibacterial drugs. Specifically, the document explains the agency’s current thinking about possible streamlined development programs and clinical trial designs
Drugs
Teva says that an FDA draft guidance on pre-submission facility correspondence associated with priority ANDA submissions seeks information that goes above and beyond what was included in the commitment letter for reauthorization of the Generic Drug User Fee Act. “The pre-submission facility correspondence guidance exceeds the details included
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Absonutrix Greensboro, NC (7/25): FDA recently reviewed the firm’s Web site (www.absonutrix.com) and determined that dietary supplements marketed by the firm are considered new drugs
Devices
FDA has cleared a Xavant Technology 510(k) for the Stimpod NMS460, a hybrid-pulsed radio frequency waveform neuromodulation device for relieving and managing chronic intractable pain, as well as an adjunctive treatment in managing post-surgical pain, post-traumatic acute pain problems, and an adjunct for pain control due
Devices
Sen. Richard Blumenthal (D-CT) has introduced a bill (S 1656) to amend the federal Food, Drug, and Cosmetic Act to provide cybersecurity protections for medical devices. The measure would create a cyber “report card” for medical devices and require manufacturers to obtain consent from healthcare providers before remotely accessing
Drugs
Four stakeholder organizations are praising the FDA program for enhanced review transparency and communication statement of work that was negotiated as part of the Biosimilars User Fee Agreement. The Association for Accessible Medicines (formerly the Generic Pharmaceutical Association) and its Biosimilars Council say the need to provide adequate agency resources