Devices
FDA has issued a draft guidance, Medical X-Ray Imaging Devices Conformance with IEC Standards, to harmonize performance standards under the Federal Food, Drug, and Cosmetic Act with International Electrotechnical Commission (IEC) standards, where appropriate, to help ensure streamlined regulatory review for submissions for medical x-ray imaging equipment. The
Drugs
Imarch Research says that FDA issued just five Warning Letters to clinical investigators in FY 2015 as a result of the agency’s Bioresearch Monitoring Inspection Program. An online post says that only two types of violations were cited in the letters. Failing to ensure that the investigation was conducted
Drugs
FDA has denied a 1/10/14 Jame Fine Chemicals (JFC) petition asking the agency to reconsider its decision to close a drug efficacy study implementation docket that left standing a prior determination that certain products identified in the docket were less than effective and could be introduced into interstate
Drugs
FDA has approved in part and denied in part petitions filed by Ken Suprenant, a Michigan man whose wife died from rare adverse effects of chemotherapy, asking that the agency revise prescribing information for fluorouracil injection and Xeloda (capecitabine) to clarify the risk of severe toxic reactions in patients with
Devices
FDA has approved a W.L. Gore & Associates PMA for the Gore Tigris Vascular Stent, a dual-component stent with a fluoropolymer/nitinol design. The device was designed to improve anatomical conformability with the natural movement of the knee when treating peripheral artery disease, the company says. “The stent
Drugs
Pfizer says it has reached a $486 million settlement with shareholders for allegedly concealing safety risks associated with its Celebrex and Bextra pain drugs. The company says the deal is “subject to the negotiation of a final settlement agreement and court approval.” Shareholders accused the company of hiding clinical trial
Drugs
FDA and the HHS Office for Human Research Protections have issued a joint guidance to assist institutional review board (IRB) administrators, chairs, and other officials responsible for preparing and maintaining written procedures for the IRB. The guidance provides an IRB written procedures checklist incorporating the HHS and FDA regulatory requirements
Devices
A 5/2016 FDA draft guidance on technical considerations for additive manufactured (AM) devices is the agency’s first attempt to determine its regulation of the burgeoning 3D printing industry. Attorneys Suzan Onel and Jacqueline Chan (K&L Gates) write in an online blog post that FDA’s approach
Biologics
FDA has given ADMA Biologics a complete response letter for a BLA for RI-002, an investigational therapy for treating primary immunodeficiency (PI) patients. The letter identified certain outstanding inspection issues and deficiencies at ADMA’s third-party contract manufacturers, including its contract drug substance and product manufacturer, and its
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. American Specialty Pharmacy, Inc. Plano, TX (6/28). Inspected 12/9-19/14. GMP deviations, unapproved new drugs, adulterated, misbranded: The firm does not have any FDA approved applications
FDA Policy/General
Federal Register Notice: The Office for Human Research Protections, Office of the Assistant Secretary for Health, and FDA are making available a draft guidance entitled Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs. Its purpose is to assist IRB administrators, IRB chairpersons, and other institutional officials responsible
FDA Policy/General
Federal Register Notice: FDA has determined that Samsca (tolvaptan) tablets, 60 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow the agency to approve abbreviated new drug applications (ANDAs) for tolvaptan tablets, 60 mg, if all other legal and regulatory requirements are met.
FDA Policy/General
Federal Register Notice: FDA is making available a document entitled Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use — Compliance Policy; Guidance for Industry. This guidance addresses the regulatory requirements for determining donor eligibility that apply to establishments that collect blood and blood
FDA Policy/General
Federal Register Notice: FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify the agency in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve
Devices
FDA and the Centers for Medicare and Medicaid Services (CMS) have accepted a Foundation Medicine PMA for FoundationOne for a “parallel review” in order to expedite reviews of the oncologic comprehensive genomic profiling assay. FDA also accepted the company’s request for review as part of its Expedited Access Pathway
Drugs
Foley & Larder says a recent complaint filed under Section 337 of the Tariff Act at the International Trade Commission (ITC) on behalf of Par Pharmaceutical and related parties will be heard by an administrative law judge. The complaint alleges that potassium chloride powder products are being unlawfully imported into
Drugs
The DC federal court has ruled in FDA’s favor in a lawsuit brought by Otsuka that sought to reverse the agency’s approval of Alkermes’ 505(b)(2) NDA for Aristada (aripiprazole lauroxil) extended-release injectable suspension. The 2015 agency Aristada approval came after it denied an Otsuka petition
Devices
The Justice Department has filed suit against Jerome Hahn (Lexington, KY) and a medical device company he owns, Telehealth Holdings, for allegedly violating the False Claims Act. According to the complaint, Hahn and his company defrauded the government by submitting false claims in connection with three federal grants worth over
Devices
CDRH has posted a guidance on “FY 2017 Medical Device User Fee Small Business Qualification and Certification” that describes the process for requesting qualification and certification as a small business in order to allow reduced user fees. A small business designated company must have gross receipts or sales of no
Drugs
FDA has approved an Ipsen sBLA for Dysport (abobotulinumtoxinA) for injection for treating pediatric lower limb spasticity in children two years of age and older. Approval was based on data from a Phase 3 pivotal study that showed the majority of patients achieved a response lasting 16 to 22 weeks
Drugs
FDA has issued the University of Michigan an eight-observation Form-483 about pharmacy compounding violations it observed during a June inspection. The document said university investigations into batch failures did not extend to other drug products that may have been associated with the specific discrepancy/failure. The agency also
Drugs
FDA officials say the agency will begin piloting a new inter-Center consult request (ICCR) procedure for proposed combination products. In a new agency blog post, they say that “close inter-Center collaboration and communication are important to facilitate timely, appropriately-tailored and well-informed submission review. A combination product