FDA Policy/General
President Trump’s just-released fiscal year 2018 budget blueprint is meeting significant resistance from FDA constituencies over a proposed doubling of FDA user fees on regulated industry’s medical product marketing applications, to about $2 billion annually. Such a jump “replaces the need for new budget authority to cover
FDA Policy/General
FDA will publish in the 3/17 Federal Register a notice revising Chapter I of its regulations to reflect changes to the agency’s organizational structure, including dissolution of the Regional Food and Drug Director position. The notice says the revisions replace references to the Regional Food and Drug Director,
FDA Policy/General
Federal Register notice: FDA has determined that cyanocobalamin injection, 1 milligram per milliliter in a 10 milliliter vial, was not withdrawn for reasons related to safety or effectiveness. This determination means that the agency will continue to approve ANDAs that refer to the product as long as they meet relevant
Drugs
Sen. Richard Durbin (D-IL) has introduced two bills to provide steady increases for biomedical and scientific research at a number of federal research agencies. In a statement, Durbin says the bills “will allow America’s best scientists and researchers to spend less time worrying about their budgets and more
Drugs
Alkermes says it has started a new Phase 3 trial of its ALKS 8700, a novel, oral monomethyl fumarate prodrug candidate in development for treating relapsing forms of multiple sclerosis. The five-week head-to-head study is to evaluate the gastrointestinal tolerability of ALKS 8700 compared to Tecfidera (dimethyl
Drugs
FDA has accepted an Asana BioSciences IND for ASN002, a novel dual SYK-JAK inhibitor, for treating atopic dermatitis. In the submission, the company proposes a Phase I randomized, double-blind, placebo-controlled, multiple dose escalation study to evaluate the therapy’s safety and tolerability as well as preliminary efficacy
FDA Policy/General
The Government Accountability Office (GAO) says that since its 2011 report, FDA and the Agriculture Department have made progress in overseeing use of medically important drugs in food animals, but still more needs to be done. The agency’s report says that since 2011, FDA has increased veterinary oversight of
Drugs
Citing rising abuse concerns, FDA’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees have voted 18 to 8 that that the benefits of reformulated Opana ER (oxymorphone hydrochloride extended release) no longer outweigh its risks. Several panel members recommended that the drug stay on
FDA Policy/General
Federal Register Notice: FDA has extended the comment period for a 1/18 notice regarding a guidance on “Considerations in Demonstrating Interchangeability with a Reference Product.” The document is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes
FDA Policy/General
Federal Register Notices: FDA has posted 10 Office of Management and Budget information collection notices, nine of them health product-focused, that have been backlogged and now released after a regulatory review by the Trump administration. The nine are: * Comment Request: Testing Communications on Medical Devices and Radiation-Emitting Products.
FDA Policy/General
Federal Register Final Order: FDA has classified as a Class 2 (special controls) medical device the continuous glucose monitor secondary display. The special controls that will apply to the device are identified in the order and will be part of the codified language. To view the order, click here.
FDA Policy/General
Federal Register Final Order: FDA has classified as a Class 2 (special controls) medical device the high throughput genomic sequence analyzer for clinical use. The special controls that will apply to the device are identified in the order and will be part of the codified language. To view the order,
FDA Policy/General
Federal Register Final Order: FDA has classified as a Class 2 (special controls) medical device the vibratory counter-stimulation device. The special controls that will apply to the device are identified in the order and will be part of the codified language. To view the order, click here.
Drugs
Four Republican leaders of the House Energy and Commerce Committee have asked FDA for documents relating to two closed Office of Criminal Investigation (OCI) investigations into the 2007-2008 heparin contamination crisis. In a 3/15 letter to FDA acting commissioner Stephen Ostroff, the four say the committee is continuing
Drugs
Amgen’s Supreme Court opening and response brief in Sandoz v. Amgen cautions that there will be “chaos” in the biosimilar world if the court rules against Amgen’s positions on the Biologics Price Competition and Innovation Act’s (BPCIA) 180-day notice of biosimilar marketing and patent dance provisions.
Devices
FDA has cleared a Millar, Inc. 510(k) for its Mikro-Cath Pressure Catheter for use in monitoring intracompartmental and airway pressures. This expanded 510(k) adds to the Mikro-Cath’s previous clearance for use in cardiovascular pressure monitoring. The device “provides the advantage of acquiring high-fidelity data
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) for treating adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after three or more prior lines of therapy. The accelerated approval was based on tumor response rate and durability of response, according to the company. Data from
Drugs
An FDA drug safety alert warned 3/15 that Allergan’s Viberzi (eluxadoline), a therapy used to treat irritable bowel syndrome with diarrhea, should not be used in patients who do not have a gallbladder. An agency review concluded these patients have an increased risk of developing serious pancreatitis that
Drugs
The Health Subcommittee of the House Energy and Commerce Committee will hold a 3/22 hearing on “Examining FDA’s Prescription Drug User Fee Program.” Subcommittee chairman Michael Burgess (R-TX) says the hearing “will examine how this important user fee program has been implemented since it was reauthorized in
Drugs
Federal Register notice: FDA has announced a 3/29 Oncologic Drugs Advisory Committee meeting that will review a Genentech BLA for rituximab/hyaluronidase injection for subcutaneous use. The proposed indications are for: (1) Treating patients with relapsed or refractory, follicular lymphoma as a single agent; (2) previously untreated follicular lymphoma
FDA Policy/General
Federal Register notice: FDA has announced a 4/5 public workshop on “Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives.” The meeting will provide an overview of the current status of regulatory science initiatives for generic drugs and an opportunity for public input on these areas. FDA will
Drugs
A Colordao federal judge has granted a permanent injunction against EonNutra, CDSM, and HABW, manufacturers and distributors of unapproved drugs and dietary supplements, and their owner, Michael Floren, requiring the businesses to immediately cease operations until they comply with federal law. An FDA news release says Floren marketed products on