FDA Policy/General
Federal Register Notice: FDA is announcing the fee rates and payment procedures for fiscal year 2017 generic new animal drug user fees: $232,400 for each abbreviated application for a generic new animal drug other than those subject to the criteria in section FDCA 512(d)(4); $116,200 for
FDA Policy/General
Federal Register Notice: FDA is establishing a public docket for comment on the agency’s blood donor deferral recommendations for reducing the risk of human immunodeficiency virus (HIV) transmission as described in the document entitled Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood
FDA Policy/General
Federal Register Notice: FDA is announcing the rates for prescription drug user fees for fiscal year 2017: for an application requiring clinical data ($2,038,100), for an application not requiring clinical data or a supplement requiring clinical data ($1,019,050), for an establishment ($512,200), and for a
FDA Policy/General
Federal Register Notice: FDA is announcing the rates for ANDAs ($70,480), prior approval supplements to an approved ANDA ($35,240), drug master files ($51,140), generic drug active pharmaceutical ingredient facilities ($44,234), foreign API facility ($59,234), and finished dosage form facilities ($258,646) and foreign finished dosage
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance: Use of Real-World Evidence to Support Regulatory Decisionmaking for Medical Devices. The agency is issuing this draft guidance to clarify how it evaluates real-world data (RWD) to determine whether it may be sufficiently relevant and reliable to generate
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled Adaptive Designs for Medical Device Clinical Studies. It provides sponsors and FDA staff with guidance on how to plan and implement adaptive designs for clinical studies when used in medical device development programs. An adaptive design for a medical device
FDA Policy/General
Federal Register Notice: FDA will hold a meeting 10/13 of the Vaccines and Related Biological Products Advisory Committee. The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2017 southern hemisphere influenza
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
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
Continued government losses in lower courts involving First Amendment-related off-label drug marketing cases raise the specter that FDA’s entire pre-market approval regime could be in jeopardy, according to University of Arizona law professor Christopher Robertson. Writing in an Arizona Legal Studies discussion paper, Robertson notes how
FDA Policy/General
BIOLOGICS Workshop on Pre-clinical Evaluation of Red Blood Cells Federal Register Notice: FDA will hold a public workshop 10/6-7 entitled “Pre-Clinical Evaluation of Red Blood Cells for Transfusion.” Its purpose is to discuss new methodologies for pre-clinical evaluation of the safety and efficacy of red
FDA Policy/General
DEVICES FDA has approved an Asuragen de novo submission to allow marketing of the QuantideX qPCR BCR-ABL IS Kit, the first nucleic acid-based quantitation test for use during treatment of chronic myeloid leukemia (CML) patients. The device uses blood specimens from patients with CML to measure the amount
FDA Policy/General
Chronos Therapeutics has acquired three pre-clinical development programs targeting central nervous system diseases from a subsidiary of Shire. Chronos has acquired all intellectual property, know-how, development and marketing rights for each program, and Shire becomes a strategic equity investor in Chronos and is eligible for milestone payments on
FDA Policy/General
FDA comes under stringent criticism in the GOP Platform 2016 adopted during the Republican National Convention that concluded in Cleveland, OH 2/22. Pledging to reform the agency, the document says FDA is now threatening “America’s leadership in life sciences R&D and medical innovation” through a “lack
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for NeurogesX, Inc.’s Qutenza (capsaicin) is 2,944 days for extending a patent that claims the human drug product. Qutenza is indicated for managing neuropathic pain associated with postherpetic neuralgia. To view this notice, click here.
FDA Policy/General
Federal Register Direct final rule: FDA is confirming the effective date of 8/17 for the direct final rule that appeared in the 4/4 Federal Register amending the regulations describing lesser administrative actions that may be imposed on an Institutional Review Board that has failed to comply with applicable
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Acts,” has been submitted to the Office of Management and Budget for review and