Drugs
Attorney Chittam Thakore (Womble Carlyle) says that since biosimilar litigation is poised to gain momentum, early court decisions on rudimentary although fundamental questions about the Biologics Price Competition and Innovation Act (BPCIA) will be guiding lawyers and companies as they decide “whether to dance.” Writing in an online blog post,
Devices
FDA has issued a guidance, Adaptive Designs for Medical Device Clinical Studies, to give sponsors suggestions on how to plan and implement adaptive designs for clinical studies when used in medical device development programs. The document defines an adaptive design for a medical device clinical study as a clinical study
Devices
FDA has issued a draft guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, to clarify how the agency uses real-world data to determine whether it may be sufficiently relevant and reliable to generate the types of real-world evidence that can be used
Drugs
A 3/3-14 FDA inspection at ALK-Abello A/S, Horsholm, Denmark, found deviations from current good manufacturing practice requirements in the manufacture of licensed biological drug products and intermediates, according to a 7/15 Notice of Violation. The letter says that significant violations shown on an FDA-483
FDA Policy/General
The 2016 Democratic Party Platform released in advance of this week’s convention in Philadelphia is silent on FDA and any reform ideas. This is in sharp contrast to last week’s GOP Platform 2016 document that highly criticized the agency and pledged reforms (see story). Despite the absence of
Drugs
A federal grand jury has returned an indictment charging two Florida residents and one North Carolina resident with manufacturing and distributing performance-enhancing drugs in violation of FDA regulations. William Bagwell (Petersburg, FL), Cole Leggett (Clearwater, FL) and Robert Nicholson-Gould (Lexington, NC) allegedly conspired to manufacture and distribute various
Devices
CDRH says early feasibility studies conducted in the U.S. can give medical device developers important FDA feedback early in the development process, which may improve the development strategy and reduce the chances that unnecessary testing is completed. Speaking on a device clinical trial webinar (view recording/view transcript) earlier
Drugs
FDA says it has approved safety labeling changes for fluoroquinolone antibiotics to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections. An agency news release says that while the drugs are effective in treating serious
Drugs
The stakes are increasing for drug, biologic and medical device companies exposed to False Claims Act (FCA) lawsuits that are often brought by whistleblowers. Effective 8/1, the Department of Justice (DoJ) will nearly double the per-claim penalties it imposes under the FCA. According to a recent interim final
Devices
Attorney Gail Javitt (DLA Piper) says that a recent FDA draft guidance on agency oversight of certain applications of next generation sequencing (NGS)-based technology leaves several threshold questions unanswered. Writing in an online post, Javitt says that the standards proposed in the guidance address areas including test design considerations,
Devices
Democratic leaders on the House Energy and Commerce Committee are asking FDA and the Centers for Medicare and Medicaid Services (CMS) for information on how regulators are working with Theranos to ensure that the company complies with federal regulatory standards and addresses concerns about its flawed blood test results. Letters
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986 as Amended by the Family Smoking Prevention and Tobacco Control Act,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act
FDA Policy/General
Federal Register Notice: FDA is releasing a publication containing modifications it is making to the list of standards the agency recognizes for use in premarket device reviews entitled Modifications to the List of Recognized Standards, Recognition List Number: 044. It aims to assist manufacturers who elect to declare conformity with
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry and FDA staff entitled Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI). The draft document will define the expected content and forms of the UDI, to assist both labelers and FDA-accredited issuing
FDA Policy/General
Federal Register Final order: FDA is issuing a final order to reclassify iontophoresis devices intended for any other purposes, which are preamendments Class 3 devices (regulated under product code EGJ), into Class 2 (special controls) and to amend the device identification to clarify that devices intended to deliver specific drugs
FDA Policy/General
Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor for 57 approved new animal drug applications and 14 approved ANADAs from Elanco Animal Health, A Division of Eli Lilly & Co. to Elanco U.S., Inc. To view this final rule, click
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Ageless Aesthetics, Inc. Aurora, CO (7/18). Reviewed Web site at the http://medik8.us/ in June. Some of the Web site claims that provide evidence that the products
Drugs
Alzheon says it is moving its Alzheimer’s disease drug candidate (ALZ-801) into a pivotal Phase 3 program after reporting positive results from two Phase 1b studies. ALZ-801 is an optimized prodrug of tramiprosate, according to the company. The Phase 1b study results demonstrated “favorable gastrointestinal tolerability, consistent
Devices
FDA has cleared a BioTelemetry 510(k) for its next generation Mobile Cardiac Outpatient Telemetry device, the MCOT Patch. The Patch is a four-lead, two-channel system that, through the use of a proprietary algorithm, provides remote arrhythmia detection. The device incorporates proprietary “patch technology” that the company recently
Drugs
Drug manufacturing process reviews by CDER’s Office of Process & Facilities are being integrated with the facility evaluations, Division of Process Assessment branch chief Ubrani Venkataram told a 7/22 CDER Office of Pharmaceutical Quality Symposium webinar. The ongoing integration project is a top priority for the Office and
Drugs
One of the common deficiencies cited during drug preapproval inspections is inadequate process design or justification for the commercial process/control strategy, CDER Office of Pharmaceutical Quality Division of Inspectional Assessment quality assessment lead Quallyna Porte told a 7/22 Pharmaceutical Quality Symposium webcast. Porte said inspection teams typically have
Biologics
Amgen and UCB have filed a BLA for romosozumab, an investigational monoclonal antibody for treating osteoporosis in postmenopausal women who have increased fracture risks. “Romosozumab works by binding and inhibiting sclerostin, a protein naturally occurring in the bone, thereby increasing bone formation and decreasing bone resorption,” the companies say. The